BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Report
- Report Number
- 3003152976-2022-00028
- Event Type
- Malfunction
- Date Received
- January 27, 2022
- Date of Event
- January 10, 2022
- Report Date
- March 2, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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. 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. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS VERIFIED THE BOX WAS LABELED AS 50ML LL ITEM 300223, LOT 2112084, HOWEVER, 20ML LL BULK BAGS OF ITEM 300220, LOT 2112083 WERE PACKAGED INSIDE THE BOX. A DEVICE HISTORY REVIEW WAS PERFORMED FOR BOTH LOTS 2112084 AND 2112083, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THIS INCIDENT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. THROUGH OUR INVESTIGATION IT WAS IDENTIFIED THAT BOTH LOTS WERE MANUFACTURED AT THE SAME TIME. WHEN THE APPROPRIATE AMOUNT OF BAGS WERE FILLED TO COMPLETE A PALLET, THEY WERE TRANSFERRED FROM ASSEMBLY TO THE PACKAGING ZONE IN UNLABELED BOXES. WHEN THE OPERATOR PLACED THE LABELS FOR EACH BOX, THEY PLACED THE LABEL FOR THE 50ML LL SYRINGES INSTEAD OF THE CORRECT 20ML LL SYRINGES THAT CORRESPONDS TO THE PRODUCT THAT WAS ACTUALLY WITHIN THE PACKAGING BOX. CAPA 4493520 HAS BEEN OPENED TO ADDRESS THIS DEFECT.
IT WAS REPORTED THAT 12 BOXES OF BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE MISLABELED, CONTAINING THE INCORRECT SYRINGE GAUGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PACKAGING SUPPLIER REPORTS THAT 1 PALLET OF 12 BOXES WHICH SHOULD CONTAIN 50/60ML SYRINGES DID NOT CONTAIN 50/60ML SYRINGES, BUT 20ML SYRINGES. ALL 12 BOXES CONTAIN 20ML SYRINGES. AND HAVE A LABEL OF 50ML SYRINGES. THE CASE IS LABELED ITEM 300223, LOT 2112084. PRODUCT INSIDE IS SHOWN AS ITEM 300220, LOT 2112083.
IT WAS REPORTED THAT 12 BOXES OF BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE MISLABELED, CONTAINING THE INCORRECT SYRINGE GAUGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PACKAGING SUPPLIER REPORTS THAT 1 PALLET OF 12 BOXES WHICH SHOULD CONTAIN 50/60ML SYRINGES DID NOT CONTAIN 50/60ML SYRINGES, BUT 20ML SYRINGES. ALL 12 BOXES CONTAIN 20ML SYRINGES. AND HAVE A LABEL OF 50ML SYRINGES. THE CASE IS LABELED ITEM 300223, LOT 2112084. PRODUCT INSIDE IS SHOWN AS ITEM 300220, LOT 2112083.
IT WAS REPORTED THAT 12 BOXES OF BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE MISLABELED, CONTAINING THE INCORRECT SYRINGE GAUGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PACKAGING SUPPLIER REPORTS THAT 1 PALLET OF 12 BOXES WHICH SHOULD CONTAIN 50/60ML SYRINGES DID NOT CONTAIN 50/60ML SYRINGES, BUT 20ML SYRINGES. ALL 12 BOXES CONTAIN 20ML SYRINGES. AND HAVE A LABEL OF 50ML SYRINGES. THE CASE IS LABELED ITEM 300223, LOT 2112084. PRODUCT INSIDE IS SHOWN AS ITEM 300220, LOT 2112083.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60124 | BD PLASTIPAK¿ LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2112084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |