BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE
Report
- Report Number
- 3003152976-2022-00013
- Event Type
- Malfunction
- Date Received
- January 24, 2022
- Date of Event
- January 3, 2022
- Report Date
- February 15, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111083. MEDICAL DEVICE EXPIRATION DATE: 2026-10-31. DEVICE MANUFACTURE DATE: 2021-11-10. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111083. MEDICAL DEVICE EXPIRATION DATE: 2026-10-31. DEVICE MANUFACTURE DATE: 2021-11-10. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/28/2022. H.6. INVESTIGATION: SAMPLES RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, SAMPLES PROVIDED BY CUSTOMER ARE NOT USED AND ALL OF THEM WERE SENT WITH THEIR ORIGINAL UNITARY PACKAGING. STOPPER IS CORRECTLY ASSEMBLED IN ALL OF THEM. SOME OF THE SYRINGES PRESENT A DEFECT IN THE BARREL THAT CAN BE RELATED WITH THE DEFECT EXPERIENCED BY CUSTOMER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111083 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS DAMAGE IN THE BARREL DEFORM THE PART IMPEDING A GOOD ADJUSTMENT AND SEALING BETWEEN THE BARREL, STOPPER AND PLUNGER LEADING TO LEAKAGE.
IT WAS REPORTED THAT 1 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE EACH FROM LOTS 2111083 AND AN UNSPECIFIED LOT HAD ISSUES WITH CHEMOTHERAPY MEDICINE LEAKING PAST THEIR STOPPERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WE ARE EXPERIENCING A QUALITY DEFECT ON BD PLASTIPAK 10ML SYRINGES (REFERENCE (B)(4), LOT 2111083 (EXPIRATION 10/31/2026). PLEASE NOTE THAT THE DEFECT ALSO OCCURRED LAST WEEK WITH ANOTHER LOT, WHICH WE UNFORTUNATELY DID NOT NOTE. WHEN SAMPLING FROM A SOLVENT BAG OR FROM AN ANTICANCER VIAL, SOME LIQUID GETS UNDER THE SEAL, OR EVEN ALONG THE PLUNGER... THIS IS VERY ANNOYING BECAUSE WE PREPARE ANTICANCER DRUGS AND THIS DEFECT LEADS TO EXPOSURE OF THE STAFF, A RISK OF CROSS-CONTAMINATION, AND A LOSS OF EXPENSIVE PRODUCT." "THIS DEFECT LED TO THE EXPOSURE OF OUR PREPARERS TO CYTOTOXICS. HOWEVER, THIS EXPOSURE WAS LIMITED BY THE FACT THAT THEY WERE HANDLED IN AN ISOLATOR AND WORE THREE PAIRS OF GLOVES, SO THERE WERE NO IMMEDIATE PHYSICAL ADVERSE CONSEQUENCES. HOWEVER, IT DID LEAD TO AN INCREASE IN WORKLOAD FOR THEM (THOROUGH CLEANING, NEED FOR RE-FABRICATION)."
IT WAS REPORTED THAT 1 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE EACH FROM LOTS 2111083 AND AN UNSPECIFIED LOT HAD ISSUES WITH CHEMOTHERAPY MEDICINE LEAKING PAST THEIR STOPPERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WE ARE EXPERIENCING A QUALITY DEFECT ON BD PLASTIPAK 10ML SYRINGES (REFERENCE (B)(4), LOT 2111083 (EXPIRATION 10/31/2026). PLEASE NOTE THAT THE DEFECT ALSO OCCURRED LAST WEEK WITH ANOTHER LOT, WHICH WE UNFORTUNATELY DID NOT NOTE. WHEN SAMPLING FROM A SOLVENT BAG OR FROM AN ANTICANCER VIAL, SOME LIQUID GETS UNDER THE SEAL, OR EVEN ALONG THE PLUNGER... THIS IS VERY ANNOYING BECAUSE WE PREPARE ANTICANCER DRUGS AND THIS DEFECT LEADS TO EXPOSURE OF THE STAFF, A RISK OF CROSS-CONTAMINATION, AND A LOSS OF EXPENSIVE PRODUCT." "THIS DEFECT LED TO THE EXPOSURE OF OUR PREPARERS TO CYTOTOXICS. HOWEVER, THIS EXPOSURE WAS LIMITED BY THE FACT THAT THEY WERE HANDLED IN AN ISOLATOR AND WORE THREE PAIRS OF GLOVES, SO THERE WERE NO IMMEDIATE PHYSICAL ADVERSE CONSEQUENCES. HOWEVER, IT DID LEAD TO AN INCREASE IN WORKLOAD FOR THEM (THOROUGH CLEANING, NEED FOR RE-FABRICATION)."
IT WAS REPORTED THAT 1 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE EACH FROM LOTS 2111083 AND AN UNSPECIFIED LOT HAD ISSUES WITH CHEMOTHERAPY MEDICINE LEAKING PAST THEIR STOPPERS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WE ARE EXPERIENCING A QUALITY DEFECT ON BD PLASTIPAK 10ML SYRINGES (REFERENCE 305959), LOT 2111083 (EXPIRATION 10/31/2026). PLEASE NOTE THAT THE DEFECT ALSO OCCURRED LAST WEEK WITH ANOTHER LOT, WHICH WE UNFORTUNATELY DID NOT NOTE. WHEN SAMPLING FROM A SOLVENT BAG OR FROM AN ANTICANCER VIAL, SOME LIQUID GETS UNDER THE SEAL, OR EVEN ALONG THE PLUNGER... THIS IS VERY ANNOYING BECAUSE WE PREPARE ANTICANCER DRUGS AND THIS DEFECT LEADS TO EXPOSURE OF THE STAFF, A RISK OF CROSS-CONTAMINATION, AND A LOSS OF EXPENSIVE PRODUCT." "THIS DEFECT LED TO THE EXPOSURE OF OUR PREPARERS TO CYTOTOXICS. HOWEVER, THIS EXPOSURE WAS LIMITED BY THE FACT THAT THEY WERE HANDLED IN AN ISOLATOR AND WORE THREE PAIRS OF GLOVES, SO THERE WERE NO IMMEDIATE PHYSICAL ADVERSE CONSEQUENCES. HOWEVER, IT DID LEAD TO AN INCREASE IN WORKLOAD FOR THEM (THOROUGH CLEANING, NEED FOR RE-FABRICATION)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833652 | BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | SEE SECTION H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |