Tego™ D1005Recalls & reported problems
Icu Medical, Inc. · Tego™ Connector · Class 2
Quick summary
This ICU Medical Tego connector is a small cap used on central lines and catheters for infusions, dialysis and blood draws. The 31 reports mostly describe the yellow cap cracking, breaking or splitting, sometimes leaking fluid or blood, and coming apart days after it was placed on a patient; one report mentions blood loss and one injury, with no deaths. There are no recalls naming this device, and no reports were filed in the past 12 months compared with 3 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00840619069216), received between May 21, 2019 and May 9, 2025 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Crack” (16 reports).
2 other recalls cover devices cleared under the same FDA submission (K053106); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack16
- Break7
- Fluid/Blood Leak5
- Disconnection2
- Infusion or Flow Problem2
- Air/Gas in Device1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Blood Loss4
- No Consequences Or Impact To Patient3
- Insufficient Information2
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Crack; Crack
THE EVENT INVOLVED A TEGO® CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE YELLOW TEGO CAP CRACKED AT THE YELLOW LUER LOCK WHEN DISCONNECTING A PATIENT FROM THE APHERESIS MACHINE. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995982 ↗MalfunctionMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TEGO® CONNECTOR. THE CUSTOMER REPORTED THAT THE YELLOW TEGO DEVICE WAS LEAKING AT THE CLEAR AND YELLOW CONNECTION/JUNCTION AREA. THIS OCCURRED DURING A FLUSH WITH NSS (NORMAL SALINE) AT THE ACCESS LOCATION. THERE WAS NO REPORT OF ANY HUMAN HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21989668 ↗MalfunctionJan 19, 2025Break; Break
THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED EIGHT REPORTEDLY BROKEN TEGO® CONNECTORS. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187956 ↗MalfunctionOct 31, 2024Crack; Crack
IT WAS REPORTED THAT A TEGO¿ CONNECTOR WAS FOUND TO HAVE A CRACK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT 9 CENTRAL LINE TEGO CONNECTOR CAPS HAVE BEEN CRACKED SINCE APRIL 2024. THE PRODUCT IS CRACKING ON THE YELLOW THREADS DURING FLUSHING WITH A SALINE SYRINGE OR WITHDRAWING BLOOD FOR LABS. THE CRACKS ARE BEING NOTED 3-7 DAYS AFTER BEING PLACED ON THE PATIENT'S CENTRAL LINES. IN MY REVIEW, MOST OFTEN THE PATIENTS HAD RECEIVED CHEMOTHERAPY IN THE PREVIOUS 7 DAYS AND HAD A CLOSED SYSTEM TRANSFER DEVICE (CSTD) CHEMO CLAVE ATTACHED TIGHTLY TO THE CAP. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579629 ↗MalfunctionOct 31, 2024Crack; Crack
IT WAS REPORTED THAT A TEGO¿ CONNECTOR WAS FOUND TO HAVE A CRACK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THEY NOTICED THE TEGO CAP WAS CRACKED WHEN ACCESSING THE CENTRAL LINE WITH A SALINE FLUSH. THE PATIENT HAD A BLUE DUO CAP IN PLACE PRIOR TO THE REGISTERED NURSE (RN) ACCESSING THE LINE. RN CHANGED THE TEGO CAP ONCE THE CRACK WAS NOTICED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579451 ↗MalfunctionOct 31, 2024Crack; Crack
IT WAS REPORTED THAT A TEGO¿ CONNECTOR WAS FOUND TO HAVE A CRACK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE BEST GUESS OF LOT NUMBER AS THE CAP CRACKED 7 DAYS AFTER IT WAS APPLIED TO THE PATIENT. APPROPRIATE ACTIONS WERE TAKEN BY THE NURSING STAFF WITH THE REPLACEMENT OF THE BROKEN TEGO CAP. THIS IS A KNOWN ISSUE WHEN PATIENTS HAVE MULTIPLE DAYS OF CHEMOTHERAPY, AND THE SPIROS CLOSED SYSTEM DRUG-TRANSFER DEVICE (CSTD) CAPS ARE TWISTED ON AND OFF THE TEGO CAP REPEATEDLY. APPEARS THE SPIROS CAPS WEAR DOWN THE TEGO LUER LOCK CONNECTOR. MITIGATION STRATEGIES ARE LIMITED DUE TO THE REQUIREMENT OF BOTH PIECES OF EQUIPMENT/CAPS. IT HAS THE POTENTIAL TO CHANGE TEGO CAPS MORE FREQUENTLY IN PATIENTS REQUIRING MULTIPLE CHEMO DAYS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579417 ↗MalfunctionOct 31, 2024Crack; Crack
IT WAS REPORTED THAT A TEGO¿ CONNECTOR WAS FOUND TO HAVE A CRACK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT DURING A ROUTINE BLOOD DRAW, THE PATIENT'S TEGO CAP ON THEIR PALINDROME CATHETER WAS DISCOVERED TO BE CRACKED. THE CAP WAS IMMEDIATELY REPLACED, AND THE BROKEN CAP WAS RETAINED IN A BIOHAZARD BAG WITH THE PATIENT'S LABEL ATTACHED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578876 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED YELLOW PART OF A TEGO CAP THAT WAS CONNECTED TO THE PATIENT'S DIALYSIS CATHETER WAS CRACKED. NO LOT OR BRAND NUMBER IDENTIFIED AS THE TEGO CAP HAD BEEN ON THE PATIENT SINCE (B)(6) 2024. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 5 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433190 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED WHEN PULLING OUT THE WASTE PRIOR TO FLUSHING THE LINE OF A PAL, A CRACK IN THE PLASTIC TEGO CAP WAS NOTED ALONG THE THREADED PART OF THE TEGO CAP. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 9 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431808 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED WHILE TWISTING FLUSH OFF THE LUER LOCK PORTION OF THE TEGO CAP, THE LUER LOCK PORTION CRACKED AND BECAME LOOSE FROM THE REST OF THE TEGO CAP. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 8 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431692 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED THE YELLOW PART OF PLASTIC ON THE TEGO CAP THAT WAS CONNECTED TO THE PATIENT'S HEMODIALYSIS CATHETER WAS CRACKED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 4 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431575 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED WHILE DETACHING AN INTRAVENOUS (IV) MEDICATION FROM THE PATIENT'S PALINDROME LINE, NURSE SAW CRACK IN THE LUER LOCK AREA OF THE TEGO CAP. NURSE IMMEDIATELY CLAMPED LINE AND EXCHANGED TEGO CAP FOR A NEW ONE. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 3 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431483 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED TEGO CAP WAS FOUND CRACKED BEFORE ACCESSING THE LINE, NURSE CLAMPED THE LINE CHANGED TEGO CAP. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 6 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431427 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED WHEN HOOKING UP THE PATIENT TO THEIR TRANSPLANT TUBING, THE NURSE NOTICED THAT THE PATIENT'S TEGO CAP HAD A SMALL HAIRLINE CRACK. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 7 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431321 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED THE TEGO CAP ON THE RED LUMEN WAS CRACKED BEFORE ACCESSING IT. THE LINE WAS CLAMPED AND TEGO CAP WAS CHANGED IMMEDIATELY. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 1 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431172 ↗MalfunctionOct 11, 2024Crack; Crack
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED A PATIENT RETURNED FOR AFTERNOON APPOINTMENT TO RECEIVE PLATELETS. UPON INITIATION OF PLATELETS, THE NURSE NOTICED A CRACK IN PATIENT'S TEGO CAP. LINE WAS ALREADY CLAMPED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 2 OF 9 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20430974 ↗MalfunctionOct 10, 2024Break; Break
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY OF 2024 AND INVOLVED A TEGO¿ CONNECTOR. IT WAS REPORTED ¿TEGO CAP BROKE, CAP CHANGED.¿ THE CUSTOMER STATED THERE WAS AN UNSPECIFIED SEPARATION FROM MATING CATHETER OR TUBING. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS REPORT CAPTURES 1 OF 4 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20422455 ↗MalfunctionOct 10, 2024Break; Break
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY OF 2024 AND INVOLVED A TEGO¿ CONNECTOR WHERE IT WAS REPORTED WHEN DISCONNECTING A PATIENT FROM BLOOD, THE TEGO CAP SNAPPED IN HALF WITH PART OF THE TUBING INSIDE. THE NURSE THEN APPLIED A NEW TEGO CAP AND FLUSHED LINE. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS REPORT CAPTURES 3 OF 4 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421502 ↗MalfunctionOct 10, 2024Air/Gas in Device; Air/Gas in Device
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY 2024 AND INVOLVED A TEGO¿ CONNECTOR. IT WAS REPORTED WHEN PATIENT WAS HAVING MORNING BLOOD DRAW. PATIENT'S BLOOD WAS DRAWN FROM RED LUMEN AND THEN PROCEEDED TO FLUSH BLUE LUMEN. THE PATIENT'S TEGO CAP WAS CHANGED DUE TO WEEKLY CHANGE NEEDED. THE PROVIDER WITHDREW THE INDWELLING VOLUME OF THE PALINDROME. WHEN DISCONNECTING THE SYRINGE FROM THE PALINDROME, THE PROVIDER NOTICED THAT AIR WAS SUCKED INTO THE PALINDROME. THE NURSE CLAMPED THE PALINDROME. A NEW SYRINGE WAS ATTACHED TO THE LINE AND REMOVED THE AIR IN THE PALINDROME. THE SYRINGE WAS DISCONNECTED, AND AIR ENTERED THE PALINDROME AGAIN. THE LINE WAS CLAMPED QUICKLY. THE TEGO CAP WAS REPLACED AT THIS TIME AND AIR WAS PULLED OUT OF THE LINE. SERVICE WAS NOTIFIED AND THE ISSUE CEASED AFTER CHANGING THE TEGO CAP. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421427 ↗MalfunctionOct 10, 2024Break; Break
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2024 AND INVOLVED A TEGO¿ CONNECTOR. IT WAS REPORTED WHEN THE NURSE ATTEMPTED TO CONNECT THE BLOOD TUBING TO PALINDROME, THE TEGO CAP BROKE OFF INTO THE TUBING. NURSE CLAMPED THE LINE, REPLACED TEGO CAP AND BLOOD TUBING. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS REPORT CAPTURES 2 OF 4 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20420708 ↗MalfunctionOct 10, 2024Break; Break
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY OF 2024 AND INVOLVED A TEGO¿ CONNECTOR. THE NURSE ATTEMPTED TO FLUSH AFTER DRAWING LABS AND NOTICED THE LUER-LOCK SECTION OF TEGO CAP HAD BROKEN. NURSE CHANGED CAP AND FLUSHED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS REPORT CAPTURES 4 OF 4 OCCURRENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20420481 ↗MalfunctionMay 24, 2024Crack; Crack
THE EVENT OCCURRED ON VARIOUS DATES IN THE LAST MONTH INVOLVING A TEGO® CONNECTOR DURING POST INFUSION OR PRIOR TO A BLOOD DRAW WHICH THEY REPLACED A TOTAL OF 4 TIMES. THE CUSTOMER STATED THAT THEY ATTEMPTED TO FLUSH THE CENTRAL LINE AND NOTICED THE LUER-LOCK SECTION OF THE TEGO CAP HAD CRACKED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391037 ↗MalfunctionFeb 18, 2022Break
AS RN WAS CONNECTING PATIENT TO EVENING CHEMOTHERAPY, THE TEGO CAP THAT WAS ATTACHED TO PATIENT CENTRAL LINE BROKE WITHIN THE CLOSED SYSTEM TRANSFER DEVICE (SPIROS) OF CHEMOTHERAPY TUBING. RN DISCONNECTED AND REPLACED TEGO CAP ATTACHED TO PATIENT, REQUESTED NEW DOSE OF CHEMOTHERAPY FROM PHARMACY, AND DISPOSED OF UNUSABLE MEDICATION WITH BROKEN TEGO CAP. PATIENT CHEMO WAS ADMINISTERED LATER THAN INTENDED TIME DUE TO THIS COMPLICATION.
Patient problems: Insufficient Information
MAUDE report 13558829 ↗MalfunctionFeb 18, 2022Break
TEGO CAP END HAD BROKEN OFF INTO THE SPIRO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13558802 ↗MalfunctionJan 25, 2022Crack
WHEN RN WAS REMOVING CHEMO TUBING (ATTACHED WITH SPIROS CAP), THE RN ATTACHED SALINE FLUSH AND NOTICED THAT THERE WAS A CRACK IN THE THREAD ON THE YELLOW PORTION OF THE TEGO CAP.
Patient problems: Insufficient Information
MAUDE report 13341783 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053106. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2026 · Dec 19, 2025 · Open, ClassifiedTego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Z-0988-2017 · Aug 24, 2016 · TerminatedTego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.