ICU Medical 20130-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00840619023386), received between Sep 26, 2017 and Jul 25, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (32 reports).

5 other recalls cover devices cleared under the same FDA submission (K082806); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP. THE CUSTOMER REPORTED THAT ONE OF THE SPIROS, WHICH WAS CONNECTED TO A SMITH¿S CADD, HAD BEEN LEAKING ON A PATIENT FOR 24 HOURS WHILE THEY WERE ASLEEP. THERE WAS PRESENCE OF BLOOD ON THE TUBING AND SPIROS, ALONG WITH POTENTIAL TRACES OF FLUOROURACIL. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED. THE EVENT OCCURRED ON (B)(6) 2024; HOWEVER, IT WAS ONLY NOTED ON (B)(6) 2024. THE PATIENT WASN¿T HARMED, JUST GOT SOME FLUOROURACIL ON THEIR SKIN AND SOME BEDDING. IT WAS A FIRST TIME CADD FOR THE PATIENT AND THEY WERE WORRIED ABOUT HAVING THE SAME PUMP PUT BACK ON FOR FEAR OF IT LEAKING AGAIN. MOSTLY JUST CONCERN FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826834 ↗
• MalfunctionJun 21, 2024Disconnection; Disconnection

  AN EVENT THAT OCCURRED ON AN UNKNOWN DATE INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT EXPERIENCED DISCONNECTION. THE REPORT STATED THAT THE SPIROS IS ATTACHED TO THE FILTERED EXTENSION SET. CUSTOMER HEARS THE CRACK, CONFIRMING THAT THE SPIROS SHOULD BE BONDED TO THE TUBING. AFTER HEARING THE CRACK WHEN ATTACHING THE SPIROS TO THE TUBING, THE CUSTOMER CAN EASILY REMOVE THE SPIROS OR IT COMES DISCONNECTED ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590155 ↗
• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REPORTING LEAKAGE ISSUE WITH USE OF ONE (1) 20130-01 SPINNING SPIROS CONNECTOR. IT WAS REPORTED THAT " TECHNICIAN NOTICED DRUG (CARBOPLATIN) LEAKING FROM THE SPIROS. A SECTION OF PLASTIC SEEMS TO BE MISSING ALTOGETHER FROM THE SPIROS UPON VISUAL INSPECTION". THERE WAS NO PATIENT INVOLVEMENT OR ANY REPORTED ADVERSE OPERATOR CONSEQUENCES. DEVICE RETURN: ONE (1) USED 20130-01 SPINNING SPIROS CONNECTOR ATTACHED TO A 20ML BD SYRINGE CONTAINING CARBOPLATIN AND TWO PACKAGED SPINNING SPIROS CONNECTORS LOT#'S 16-884-SJ AND 16-885-SJ. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED NO OBVIOUS VISUAL ABNORMALITIES WITH THE UNUSED PACKAGED DEVICES. DURING DECONTAMINATION PRESSURE WAS APPLIED TO THE SYRINGE WHILE THE SPINNING SPIROS WAS NOT ACTIVATED AND LEAKAGE WAS OBSERVED TO COME FROM INSIDE THE DEVICE. ENGINEERING TESTING AND ANALYSIS: THE TWO UNUSED SPINNING SPIROS CONNECTORS WERE PRESSURE LEAK TESTED PER THE APPLICABLE PRODUCT SPECIFICATION. THE RESULTS RECORDED NO PERFORMANCE ISSUES, LEAKAGES AND OR OUT OF SPEC CONDITIONS. CONT. SECTION H.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554761 ↗
• MalfunctionJun 17, 2024Blocked Connection; Blocked Connection

  COMPLAINT RECEIVED REPORTING OCCLUSION/EXTRACTION DIFFICULTIES WITH SET-UP CONSISTING OF ONE (1) 20130-01 SPINNING SPIROS; SYRINGE; VIAL ADAPTOR. IT WAS REPORTED THAT " TECHNICIAN WAS UNABLE TO WITHDRAW DRUG FROM VIAL ADAPTER. THE SYRINGE-SPIROS COMBINATION SEEMS TO JUST DRAW AIR, AND NOT ALLOW DRUG TO BE PULLED UP THROUGH THE SYRINGE". THERE WAS NO PATIENT INVOLVEMENT OR ANY REPORTED ADVERSE OPERATOR CONSEQUENCES. DEVICE RETURN: ONE USED 20130-01 SPINNING SPIROS ATTACHED TO A 10ML BD SYRINGE; GENIE VIAL ADAPTOR ATTACHED TO VIAL OF DACOGEN. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED SET-UP WAS PERFORMED. THE RESULTS RECORDED NO FUNCTIONAL OR PERFORMANCE ISSUES WITH THE RETURNED GENIE VIAL ADAPTOR. INITIAL EVALUATION OF THE 10ML SYRINGE - MATED TO THE 20130-01 SPINNING SPIROS DOCUMENTS THAT WHEN ACCESSED WOULD ONLY DRAW AIR, THUS CONFIRMING THE REPORTED PRODUCT ISSUE. CONT. SECTION H.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554760 ↗
• MalfunctionDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2021 INVOLVING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED WHILE INFUSING TOPTECAN AND MYCOPHENOLATE. THE REPORTER MENTIONED THAT THERE WERE NO OBVIOUS DEFECTS NOTED AND THE PROBLEM WAS NOTICED WHEN THE RN WAS HANGING THE MEDICATION ON THE SECONDARY LINE AND NOTICED THAT THERE WAS A LEAKAGE. THE RN WAS WEARING PPE BUT PATIENTS WERE NOT PROTECTED AS THEY DO NOT WEAR PPE. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT AND NO HARM. THIS IS THE THIRD OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101500 ↗
• MalfunctionDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) OR (B)(6) OF 2021 INVOLVING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED WHILE INFUSING TOPTECAN AND MYCOPHENOLATE. THE REPORTER MENTIONED THAT THERE WERE NO OBVIOUS DEFECTS NOTED AND THE PROBLEM WAS NOTICED WHEN THE RN WAS HANGING THE MEDICATION ON THE SECONDARY LINE AND NOTICED THAT THERE WAS A LEAKAGE. THE RN WAS WEARING PPE BUT PATIENTS WERE NOT PROTECTED AS THEY DO NOT WEAR PPE. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT AND NO HARM. THIS IS THE FIRST OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101496 ↗
• MalfunctionDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2021 INVOLVING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED WHILE INFUSING TOPTECAN AND MYCOPHENOLATE. THE REPORTER MENTIONED THAT THERE WERE NO OBVIOUS DEFECTS NOTED AND THE PROBLEM WAS NOTICED WHEN THE RN WAS HANGING THE MEDICATION ON THE SECONDARY LINE AND NOTICED THAT THERE WAS A LEAKAGE. THE RN WAS WEARING PPE BUT PATIENTS WERE NOT PROTECTED AS THEY DO NOT WEAR PPE. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT AND NO HARM. THIS IS THE SECOND OF THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101358 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED SPINNING SPIROS® CLOSED MALE LUER, RED CAP IN WHICH THE SPIROS DISCONNECTED DURING PATIENT USE CAUSING LEAK OF CHEMOTHERAPY. THE PRODUCT WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO BLOOD LOSS OR BLEED BACK REPORTED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779607 ↗
• MalfunctionOct 5, 2021Break

  PATIENT CAME FROM HOME AS A DIRECT ADMIT AFTER IV TUBING BROKE AT THE SPIRO CONNECTION. PATIENT IS ON A CONTINUOUS BLINATUMOMAB INFUSION AT HOME. INFUSION RESUMED AND NO HARM WAS NOTED TO THE PATIENT. THERE HAVE BEEN SEVERAL REPORTS OF THIS TYPE OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576351 ↗
• MalfunctionOct 29, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A SUS VOLUNTARY EVENT REPORT (# MW5096571) WAS RECEIVED ON OCTOBER 6, 2020 THAT STATED: "THE SPIROS THAT WAS ATTACHED TO THE IV TUBING HAD A CRACK IN IT AND CAUSED THE CHEMOTHERAPY MEDICATION THAT WAS BEING INFUSED TO LEAK ONTO THE PATIENT¿S SKIN.¿ ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ISSUES NOTED DURING INITIAL SET-UP/PRIMING. THE MEDICATION INFUSING WAS DECARBAZINE 610MG IN 100ML OF NORMAL SALINE AND WAS ADMINISTERED AT A RATE OF 100ML PER HOUR. AFTER THE DEVICE HAD INFUSED FOR 5 TO 10 MINUTES, A LEAK OF ABOUT 15ML WAS NOTED ON THE PATIENT¿S SHIRT. A NEW SPIROS WAS PLACED ON THE PRIMARY LINE AND THE INFUSION WAS RESUMED. THE LOCATION OF THE CRACK WAS IN THE SPIROS BODY, POPPET, HALF SEAL SUBASSEMBLY. THE MATING DEVICES USED WERE A PRIMARY PLUMSET, SECONDARY SET, AND HUBER NEEDLE. IT WAS REPORTED THAT THE CHEMO LEAK DID NOT BOTHER THE PATIENT AND THERE WAS NO REDNESS OR INJURY TO THE SKIN. THE SKIN WAS CLEANSED AND RINSED WITH WATER AND THERE WERE NO FURTHER COMPLAINTS FROM THE PATIENT.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10758000 ↗
• MalfunctionOct 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP, THAT HAD A LEAK OF DOXORUBICIN THROUGH THE BOTTOM PART OF THE SPIROS DURING AN IV PUSH ADMINISTRATION WHILE CONNECTED TO A 30ML SYRINGE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638523 ↗
• MalfunctionOct 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT LEAKED DURING A SUBCUTANEOUS AZACITIDINE ADMINISTRATION. THE SPIROS WAS ATTACHED TO A 5ML SYRINGE CONTAINING THE MEDICATION AND THE SPIROS WAS FOUND TO LEAK INTO THE OUTER CHAMBER AND SOME OF IT MADE ITS WAY OUT OF THE SYRINGE AND ONTO THE NURSE'S GLOVE. THERE WAS NO BLOOD LOSS NOR BLEED BACK AND THERE WERE NO HOLES CUTS, TEARS, OR ANY DEFECT NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR DELAY IN THERAPY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623285 ↗
• MalfunctionSep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT LEAKED DOXORUBICIN AT THE BEGINNING OF AN INFUSION. THE NURSES REPORT THE LEAK OCCURS FROM EITHER THE JOINT BETWEEN THE WHITE CAP AND THE GREY-ISH CYLINDER (SPIROS) OR FROM THE SPIROS ITSELF. ADDITIONALLY, THEY SAID IT WAS NOT LEAKING WHERE THE SYRINGE WAS CONNECTED TO THE WHITE CAP, THEREFORE IT WAS NOT A QUESTION OF THE DEVICE BEING WRONGLY CONNECTED. THERE WAS NO CONTACT OF CHEMOTHERAPY ON THE PATIENT OF HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED PER FACILITY PROTOCOL SINCE THERE WERE A FEW DROPLETS ON A DOUBLE-THICK WATERPROOF TOWEL. THERE WAS NO OBVIOUS HOLE, CUT, CRACK, RUPTURE OR DEFECT NOTED ON THE SPIROS. THE DEFECTIVE SYRINGE AND SPIROS WERE DISCARDED, AND THE WHOLE THING WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532651 ↗
• MalfunctionAug 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT LEAKED AN UNSPECIFIED INVESTIGATIONAL CHEMOTHERAPY. THE DEVICE WAS ATTACHED TO A SYRINGE. IT WAS REPORTED THE DRUG WAS SQUIRTING OUT THE SIDES OF THE SPIROS. THERE WAS NO PATIENT INVOLVEMENT NOR HARM REPORTED BUT A DELAY IN PREPARATION. THE DEVICE WAS DISCARDED BY NURSING DUE TO THE LEAK AND BIOHAZARD CONDITIONS.

  Patient problems: No Patient Involvement

  MAUDE report 10472185 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS® CLOSED MALE LUER, RED THAT LEAKED A CHEMOTHERAPY DRUG, 5-FU DURING INFUSION AND LEAKED TO THE PATIENT. THE DEVICE WAS CONNECTED TO A CADD AMBULATORY SET. THE DRUG AND TUBING WAS NOT REPLACED AND THERAPY WAS NOT RESUMED. THE CUSTOMER REPORTED THAT THE IMPACT TO THE PATIENT WAS AN INCONVENIENCE TO RETURN TO THE INFUSION SITE AND HAVE A NEW BAG PREPARED. THERE WAS A BLOOD LOSS OR BLEED BACK AS MUCH AS THE VOLUME OF PORT TUBING. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND NO SPILL KIT WAS USED. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH A DELAY IN CRITICAL THERAPY WAS REPORTED, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10468871 ↗
• MalfunctionAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS CLOSED MALE LUER, RED THAT LEAKED A CHEMOTHERAPY DRUG, 5-FU DURING INFUSION AND LEAKED TO THE PATIENT. THE DEVICE WAS CONNECTED TO A CADD AMBULATORY SET. THE DRUG AND TUBING WAS NOT REPLACED AND THERAPY WAS NOT RESUMED. THE CUSTOMER REPORTED THAT THE IMPACT TO THE PATIENT WAS AN INCONVENIENCE TO RETURN TO THE INFUSION SITE AND HAVE A NEW BAG PREPARED. THERE WAS A BLOOD LOSS OR BLEED BACK AS MUCH AS THE VOLUME OF PORT TUBING. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL AND NO SPILL KIT WAS USED. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH A DELAY IN CRITICAL THERAPY WAS REPORTED, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10468822 ↗
• MalfunctionAug 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED A CHEMOTHERAPY DRUG, BENDAMUSTINE, DURING PATIENT USE. THE MEDICATION LANDED ON PATIENT¿S SKIN AND WAS CLEANED PER PROTOCOL. THE HEALTHCARE PROVIDER WAS WEARING PROPER PPE AND THERE WAS NO REPORT OF UNPROTECTED EXPOSURE TO THE HEALTHCARE PROVIDER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10453411 ↗
• MalfunctionAug 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED A CHEMOTHERAPY DRUG, DOCETAXEL, DURING PATIENT USE. THE MEDICATION LANDED ON PATIENT¿S SKIN AND WAS CLEANED PER PROTOCOL. THE HEALTHCARE PROVIDER WAS WEARING PROPER PPE AND THERE WAS NO REPORT OF UNPROTECTED EXPOSURE TO THE HEALTHCARE PROVIDER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10453405 ↗
• MalfunctionAug 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT THE CUSTOMER REPORTED A LEAK OF GEMCITABINE. THE SPIROS WAS ATTACHED TO A BD ALARIS IV LINE. THE HEALTHCARE PROVIDER WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS PATIENT INVOLVEMENT AND THE CHEMOTHERAPY LANDED ON THE SKIN OF THE PATIENT, HOWEVER, THE AREA WAS CLEANED PER PROTOCOL AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10424487 ↗
• MalfunctionJul 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE A LEAK WAS NOTED DURING AN IV PUSH ADMINISTRATION OF DOXORUBICIN. IT WAS REPORTED THAT THE SPIROS WAS ATTACHED DIRECTLY TO THE SYRINGE AND THE LEAK OCCURRED ON A CLOTH AND NOT ON A PATIENT. THERE WAS NO BLOOD LOSS OR BLEED BACK REPORTED. THERE WAS NO ADVERSE EVENT OR HUMAN HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338032 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THE SPIROS WAS NOT LOCKING ON THE TUBING AND A LEAK WAS NOTED DURING AN INFUSION OF DOXORUBICIN. IT WAS REPORTED THAT THE LEAK WAS CONTAINED IN A SOAKER PAD. THERE WAS NO OBVIOUS DAMAGE NOTED ON THE PRODUCT. THERE WAS NO BLOOD LOSS OR BLEED BACK AND NO PATIENT HARM WAS NOTED WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313287 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2020, AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THE SPIROS WAS NOT LOCKING ON THE MATING DEVICE AND A LEAK WAS NOTED DURING A SYRINGE ADMINISTRATION OF DOXORUBICIN. IT WAS REPORTED THAT THE LEAK WAS CONTAINED IN A SOAKER PAD. THERE WAS NO OBVIOUS DAMAGE NOTED ON THE PRODUCT. THERE WAS NO BLOOD LOSS OR BLEED BACK AND NO PATIENT HARM WAS NOTED WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313281 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT LEAKED DURING USE WITH DOXORUBICIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313224 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THE SPIROS WAS NOT LOCKING ON THE MATING DEVICE AND A LEAK WAS NOTED DURING A SYRINGE ADMINISTRATION OF DOXORUBICIN. IT WAS REPORTED THAT THE LEAK WAS CONTAINED IN A SOAKER PAD. THERE WAS NO OBVIOUS DAMAGE NOTED ON THE PRODUCT. THERE WAS NO BLOOD LOSS OR BLEED BACK AND NO PATIENT HARM WAS NOTED WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312739 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THE SPIROS WAS NOT LOCKING ON THE MATING DEVICE AND A LEAK WAS NOTED DURING A SYRINGE ADMINISTRATION OF DOXORUBICIN. IT WAS REPORTED THAT THE LEAK WAS CONTAINED IN A SOAKER PAD. THERE WAS NO OBVIOUS DAMAGE NOTED ON THE PRODUCT. THERE WAS NO BLOOD LOSS OR BLEED BACK AND NO PATIENT HARM WAS NOTED WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082806. One submission often covers many models, so check the product and lot details in each record.

• Z-1723-2022 · Aug 1, 2022 · Open, Classified
  6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
• Z-1567-2021 · Mar 16, 2021 · Open, Classified
  REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of
• Z-1568-2021 · Mar 16, 2021 · Open, Classified
  REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the
• Z-1569-2021 · Mar 16, 2021 · Open, Classified
  REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration se
• Z-0702-2021 · Aug 31, 2020 · Open, Classified
  30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Sp