BD PhaSeal 515200Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00382905152009), received between Feb 5, 2018 and Dec 30, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

   Z-2453-2025 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: I HAVE A CUSTOMER WHO USED A CONNECTOR EARLIER AND IT LEAKED. PER CUSTOMER RESPONSE: THE LEAK OCCURRED BETWEEN THE TRANSFER INJECTOR AND THE LUER LOCK SYRINGE. WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? I BELIEVE SO, YES. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN ¿ NOT THAT I AM AWARE OF. WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? YES. IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED. VINBLASTINE. WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, NOT THAT I KNOW OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922443 ↗
• MalfunctionSep 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20221127 ↗
• MalfunctionAug 5, 2024Complete Blockage; Complete Blockage

  MATERIAL: 515200 LOT: 22075215 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT#: 515200 LOT#: 22075215 KAWEAH HEALTH MEDICAL CENTER 400 W. MINERAL KING AVE. VISALIA, CA 93291 I WANTED TO INFORM YOU, WE HAD USED PRODUCT BD PHASEAL LUER LOCK CONNECTOR (C35). WHILE ADMINISTERING MEDICATION TO IV LINE HALF OF THE PRODUCT WAS DISPENSED FROM SYRINGE, WHILE THE OTHER HALF WASN¿T ABLE TO PASS THROUGH. WE THOUGHT IT MIGHT HAVE BEEN LOT SPECIFIC LOT: 22075215 SO WE SEQUESTERED THE REST OF THE BATCH. WHEN WE TRIED ANOTHER C35 OF THE SAME LOT THE WITH TESTER PRODUCT (STERILE WATER) THE PRODUCT WAS ABLE TO PASS THROUGH NORMALLY. (SEE BELOW FOR SEQUESTERED LOT OF C35 AND TESTER SYRINGE) (B)(6) 2024: CAN WE FOLLOW UP AND VERIFY IF THEY USED THE SAME INJECTOR WITH A NEW CONNECTOR? DID THEY CHANGE BOTH COMPONENTS? CUSTOMER RESPONSE ON (B)(6) 2024 THE C35 WE HAVE IS THE SAME LOT AS THE INJECTOR WE ORIGINALLY USED, BUT NOT THE ORIGINAL PRODUCT THAT WAS USED, THE NURSED DISCARDED AFTER PRODUCT FAILED, SO WE TESTED WITH NEW COMPONENTS WITH SAME LOT 07AUG2024: ADDITIONAL FOLLOW UP SENT TO CUSTOMER: CAN YOU CONFIRM, DID YOU USE THE SAME INJECTOR, AFTER REPLACING THE C35 CONNECTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905247 ↗
• MalfunctionJul 9, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702650 ↗
• MalfunctionJun 19, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566334 ↗
• MalfunctionDec 4, 2023Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem

  MATERIAL#: 515200 BATCH#: 2108207. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER CALLED IN TO REPORT THAT THE NURSES ARE HAVING TROUBLE WITH THE C35 NOT PUSHING ANYTHING OUT, PRODUCT IS CLOGGED. NURSING STAFF STATED THEY WERE UNABLE TO PUSH THE DRUG AZACIDINE THROUGH THE PHASEAL AND LUER LOCK CONNECTOR. THE NURSES BEGAN REMOVING THE C35 CONNECTOR AND ADDING THE NEEDLE TO THE PHASEAL WHICH ALLOWED THEM TO PUSH IT THROUGH. NOT USING THE C35 COULD LEAD TO EXPOSURE. I HAVE SINCE REACHED OUT TO NURSING 2 MORE TIMES AND THEY HAVE NOT RESPONDED. YOU MAY CLOSE THE CASE. IF THE ISSUE OCCURS IN THE FUTURE I WILL REACH OUT TO BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255908 ↗
• MalfunctionNov 16, 2023Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  WE HAVE EXPERIENCED FLAKES OF PLASTIC COMING OFF THE PHASEAL LUER LOCK CONNECTOR (C35) TWICE ALREADY. THE SECOND TIME WAS WITH LOT 2305211. THESE PIECES OF PLASTIC GET INTO OUR INFUSION BAGS DURING CYTOSTATIC PREPARATION WHICH CAN BE VERY DANGEROUS FOR THE PATIENT. NOW WE HAVE SOLVED THIS PROBLEM BY "FISHING OUT" THE PIECE OF PLASTIC AND COLLECTING IT IN A SYRINGE. IN ATTACHMENT YOU CAN FIND THE PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154978 ↗
• MalfunctionAug 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT LEAST ONE BD PHASEAL¿ CONNECTORS LUER LOCK (C35) LEAKED BETWEEN THE INJECTOR AND CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE DETACHED THE CHEMO, TURNED AROUND AND DISPOSED THE BAG AND THE PATIENT CAUGHT OUR ATTENTION A MINUTE LATER BECAUSE BLOOD WAS RUNNING BACK OUT OF THE FEMALE PHASEAL ATTACHMENT FROM HER LINE. IT SEEMS TO ONLY BE HAPPENING WITH LONG-TERM HOOKUPS, SO OUR 24 HOUR CHEMOTHERAPY¿S. WHEN NURSES CHANGE OUT THE BAGS THE FEMALE PORT STARTS TO LEAK AFTER DISCONNECTION SOMETIMES, ALMOST LIKE WHEN THE MALE END IS REMOVED THE HUB ON THE LINE REMAINS ENGAGED INSTEAD OF CLOSING. AGAIN, THIS HAS ONLY BEEN OBSERVED WITH 24 HOUR CHEMO¿S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15177046 ↗
• MalfunctionMar 31, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO USING A BD PHASEAL¿ CONNECTOR LUER LOCK C35, FOREIGN MATTER WAS OBSERVED IN THE UNIT PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAIR SEALED INTO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967572 ↗
• MalfunctionOct 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT IS LEAKING (MULTIPLE OCCURRENCES)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624719 ↗
• MalfunctionOct 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) LEAKED FLUID WHEN DISCONNECTED FROM THE INJECTOR. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DIFFERENT NURSE TODAY, (B)(6), WITH A DIFFERENT PATIENT, DISCONNECTED THE INJECTOR FROM THE CONNECTOR AND AGAIN FLUID STARTED DRIPPING OUT OF THE CONNECTOR. IT IS ALMOST LIKE THERE IS A DELAY WHERE THE CONNECTOR ISN'T DISENGAGING THE MICRO-CLAVE ON THE LINE QUICKLY ENOUGH WHEN THE INJECTOR IS DISCONNECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595329 ↗
• MalfunctionOct 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) SPRAYED CHEMOTHERAPY MEDICINE ONTO THE PATIENT'S BED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE YESTERDAY WAS UNSURE OF WHICH CONNECTOR LEAKED ON DISCONNECTION. WE HAD ANOTHER LEAK TODAY, SO NOW WE KNOW WHICH PIECE IT IS. ON SEPT 9 THE NURSE DISCONNECTED THE MALE INJECTOR FROM THE FEMALE CONNECTOR AND CHEMO SPRAYED OUT OF THE CONNECTOR ONTO THE BED. WHEN SHE LOOKED INTO THE CONNECTOR IT WAS WET AND FULL OF FLUID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595328 ↗
• MalfunctionOct 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) SEPARATED AND LEAKED CHEMOTHERAPY MEDICINE ONTO THE PATIENT'S BED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE ON OUR FLOOR DISCONNECTED A PATIENTS CHEMO AND IT SPRAYED THE MEDICATION OUT ONTO THE BED. SHE HAD THOUGHT IT WAS THE FEMALE END AT FIRST BECAUSE WHEN SHE LOOKED AT IT THERE WAS FLUID INSIDE THE FEMALE END. BUT THAT MAKES ABSOLUTELY ZERO SENSE BECAUSE IT WAS ATTACHED TO A PICC LINE, SO NOTHING COULD FLUSH BACK. THE PICC WAS FLUSHING EASILY WITHOUT ANY BACK PRESSURE. WE THINK IT WAS ACTUALLY THE MALE END. NUMBERS SO WE WEREN¿T SURE WHICH ONE IT WAS. JUST IN CASE, THE LOT NUMBER FOR THE LUER LOCK CONNECTOR (C35) IS2011213. THE PATIENT HAD CHEMO RUNNING THROUGH, WITH AN INFUSION CLAMP IN PLACE BECAUSE IT IS AN AMBULATORY CHEMO, FOR APPROXIMATELY 23.5 HOURS. CYTOTOXIC EXPOSURE OF MEDICATION ON PATIENT'S BED LINENS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589537 ↗
• MalfunctionAug 31, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 2 BD PHASEAL¿ CONNECTORS LUER LOCK (C35) LEAKED FROM BETWEEN THE INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING BETWEEN PHASEAL INJECTOR AND CONNECTOR FOR INFUSIONS LASTING LONGER THAN 24 HOURS ON 2 PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392294 ↗
• MalfunctionNov 5, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK C35 EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING QUALITY INSPECTION, THE MEMBRANE OF C35 WAS FOUND TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10796329 ↗
• MalfunctionOct 9, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 221 BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DEVICES BEFORE USE DURING AN INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "FOREIGN MATTER CONFIRMED DURING IN-PROCESS INSPECTION".

  Patient problems: No Patient Involvement

  MAUDE report 10656102 ↗
• MalfunctionSep 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE INFUSION BAG DURING USE AFTER INJECTING ALIMTA INTO IT WITH THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THIS IS A REPORT ABOUT A COREING-LIKE INCIDENT. AFTER PREPARATION, FM WAS FOUND IN THE INFUSION BAG. THE DRUG USED IS ALIMTA."

  Patient problems: No Patient Involvement

  MAUDE report 10610998 ↗
• MalfunctionMay 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DOES NOT FIT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOXORUBICIN ADAPTER DOES NOT FIT TO INJECT THE CHEMOTHERAPY PRODUCT. THE ADAPTER WAS DISCARDED. FOR SOME TIME, NURSES HAVE BEEN EXPERIENCING DIFFICULTIES IN CORRECTLY ADAPTING THE CONNECTOR C35 PHASEAL TO THE INJECTOR N35, MAKING ITS USE IMPOSSIBLE. NURSES ARE THEREFORE OBLIGED TO REMOVE THE INJECTOR (WHICH IS ADAPTED BY THE PHARMACY WHEN THE SYRINGE IS RECONSTITUTED), RISKING EXPOSURE TO THE CHEMOTHERAPY PRODUCT CONTAINED IN THE SYRINGE. IN THE CASE CITED IN THIS STATEMENT, THE NURSE REMOVED THE INJECTOR TO DISPENSE THE PRODUCT. THE PATIENT COMPLETED THE ENTIRE COURSE OF TREATMENT. THE SYRINGE ASSEMBLY, CONNECTOR AND INJECTOR HAVE NOT BEEN KEPT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052340 ↗
• MalfunctionFeb 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DID NOT ALLOW INJECTION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPDATE AFTER ASKING IF THE DEFECT IS CLOG: THE PROBLEM WAS, THAT THERE WAS NO ACCESS. THE PHASEAL LUER LOCK CONNECTOR (C35) DID NOT ALLOW ANY INJECTION, AFTER CONNECTED TO THE INJECTOR. THE PHASEAL CONNECTOR AND THE PHASEAL INJECTOR WAS THEREFORE TAKEN OFF, AND THE INJECTION WAS GIVEN WITHOUT THE PROJECTION FROM THE PHASEAL DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759160 ↗
• MalfunctionFeb 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED FROM BETWEEN THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) AND THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MULTIPLE ISSUES OF LEAKAGE IN THE CONNECTION BETWEEN THE CONNECTOR AND A NEEDLE.".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9721551 ↗
• MalfunctionDec 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A CONNECTOR LUER LOCK C35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE EVENT TOOK PLACE DURING THE MANUAL ADMINISTRATION OF CHEMOTHERAPY PERFORMED BY THE IST. IT WAS IMPOSSIBLE TO ADAPT ONE SYRINGE TO BOTH. THE PREPARATION SERVICE WAS CALLED AND COMES TO COLLECT THE DEFECTIVE PRODUCT. THE SECOND SYRINGE FIT. ADMINISTRATION WAS CARRIED OUT ACCORDING TO THE PROTOCOL WITHOUT INCIDENTS. WHEN THE SYRINGE'S REMOVED, WHILE THE ENTIRE PRODUCT WAS BEING ADMINISTERED, A QUANTITY OF THE PRODUCT ESCAPES FROM THE SYRINGE (SAFETY ADAPTER) SPLASHING ONTO THE CARE TROLLEY. THE SERVICE MANAGER WAS INFORMED. THE PREPARATION SERVICE WAS INFORMED OF THIS. THE SYRINGE WAS KEPT IN THE SERVICE. NEITHER THE PATIENT NOR THE CAREGIVER HAD DIRECT CONTACT WITH THE CYTOTOXIC PRODUCT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512913 ↗
• MalfunctionDec 17, 2019Leak/Splash; Leak/Splash

  MATERIAL NO: 515200, BATCH NO: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ CONNECTOR LUER LOCK C35 LEAKAGE OCCURRED BETWEEN THE INJECTOR AND THE CONNECTOR. BD WAS INITIALLY MADE AWARE OF LEAKAGE ISSUE REPORTED ON (B)(4). IT WAS NOT UNTIL (B)(6) 2019 THAT THE CUSTOMER CONFIRMED THAT THERE WAS LEAKAGE BETWEEN THE INJECTOR AND CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DESCRIPTION PER SFDC PIR STATES: INFORMATION RELATED TO THE LEAKAGE WITH CHEMO PHASEAL CONNECTOR THAT I DISCUSSED WITH YOU OVER THE PHONE. THERE HAVE BEEN A FEW LEAKAGE INCIDENTS AND SOME NURSES HAVE BEEN USING ADDITIONAL TAPE TO SECURE THE CONNECTOR AND IV LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9484599 ↗
• MalfunctionNov 22, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FOLLOWING WAS SUBMITTED BY THE SALES REP: DISCONNECTS & LEAKS WHEN USING PHASEAL ON LONG TERM INFUSIONS. 2 INCIDENTS REPORTED OF N35 COMING DISCONNECTED FROM ALARIS TUBING SET. DRUG LEAKED FROM TUBING ONCE N35 WAS DISCONNECTED. RE-EDUCATION IN PHARMACY TO TIGHTEN N35 TO TUBING SET PROPERLY. WENT OVER DIFFERENCE BETWEEN FIXED COLLAR AND SLIDING COLLAR. MET WITH NURSE EDUCATOR AND WENT OVER CLAMPING AND "PULL, PAUSE, TURN, PULL WHEN DISCONNECTING N35 FROM C45. PER COMMUNICATION WITH SALES REP: AFTER A 24 HOUR INFUSION, THE N35 INJECTOR WAS MANUALLY DISCONNECTED FROM THE C45 CONNECTOR. IMMEDIATELY AFTER DISCONNECT, THERE WAS A LEAK THAT CAME THRU THE MEMBRANE OF THE C45 CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366738 ↗
• MalfunctionOct 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PHASEAL¿ CONNECTOR LUER LOCK C35. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT THE PHASEAL PRODUCTS ARE LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174913 ↗
• MalfunctionSep 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) THERE IS AN ISSUE WITH THE CONNECTION BETWEEN THE CONNECTOR AND INJECTOR. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ONCE AGAIN WE ENCOUNTER PROBLEMS WITH THE CONNECTION BETWEEN THE CONNECTOR AND INJECTOR IN THE DEPARTMENT WITH A DELIVERED CYTOSTATIC SYRINGE. THIS WAS 3 TIMES THE CASE FOR AN INTRATHECAL INJECTION ON PEDIATRIC ONCOLOGY THIS WEEK. IT IS DIFFICULT TO DETERMINE WHICH LOT NUMBER WAS USED. WE HAVE DIFFERENT LOT NUMBERS OF INJECTORS WITH CAP AND CONNECTORS IN STOCK: INJECTOR WITH CAP: 1904101, 1906110. CONNECTOR: 1905108, 1905112, 1906107.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9104841 ↗