BD PLASTIPAK¿ 3-PIECE SYRINGE
Report
- Report Number
- 2243072-2022-01473
- Event Type
- Malfunction
- Date Received
- September 6, 2022
- Date of Event
- August 12, 2022
- Report Date
- October 20, 2022
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- FMF
- UDI-DI
- 07891463002655
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
ADDITIONAL INFORMATION WAS REPORTED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PLASTIPAK¿ 3-PIECE SYRINGE HAD A DAMAGED LUER THAT APPEARED TO BE WORN DOWN TO "HALF THE ORIGINAL SIZE". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THREE RECORDS OF NON-COMPLIANCE REGARDING 3 ML LUER SLIP SYRINGES." "3ML BD LUER SLIP SYRINGES WITH DEFECTIVE NOZZLE/LUER, SHOWING "WEAR" LIMITING THE ORIFICE TO HALF THE ORIGINAL SIZE." D.1. MEDICAL DEVICE BRAND NAME: BD PLASTIPAK¿ 3-PIECE SYRINGE. D.2. MEDICAL DEVICE CATALOG#: 990581. D.2. MEDICAL DEVICE LOT#: 1179054. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON DICKINSON IND. CIRURGICAS LTDA. G.5. PMA / 510(K)#: NA. H.4. DEVICE MANUFACTURE DATE: 30-JUN-2021.
H6: INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION DAMAGED LUER CAN BE OBSERVED, THEREFORE FAILURE IS CONFIRMED. POSSIBLE ROOT CAUSE FOR DAMAGED LUER IS ASSOCIATED WITH THE ASSEMBLY PROCESS. MATERIAL JAMMING OCCURRED IN THE REJECT FLAP AND CYLINDER BELT. 1272610 (PACKAGED PRODUCT) - THE BATCH HISTORY WAS VERIFIED, AND IT WAS OBSERVED THAT THE PRODUCTION PERIOD OCCURRED BETWEEN OCTOBER 29 TO 30. THE IN-PROCESS INSPECTIONS WERE CARRIED OUT IN ACCORDANCE WITH THE CONTROL PLAN, THE RETENTION SAMPLES WERE VERIFIED AND THERE WERE NO RECORDS OF THIS INCIDENT.
IT WAS REPORTED THAT 3 UNSPECIFIED BD¿ LUER-SLIP SYRINGES HAD ISSUES WITH DAMAGED LUERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THREE RECORDS OF NON-COMPLIANCE REGARDING 3 ML LUER SLIP SYRINGES."
IT WAS REPORTED THAT THE BD PLASTIPAK¿ 3-PIECE SYRINGE HAD A DAMAGED LUER THAT APPEARED TO BE WORN DOWN TO "HALF THE ORIGINAL SIZE". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THREE RECORDS OF NON-COMPLIANCE REGARDING 3 ML LUER SLIP SYRINGES." "3ML BD LUER SLIP SYRINGES WITH DEFECTIVE NOZZLE/LUER, SHOWING "WEAR" LIMITING THE ORIFICE TO HALF THE ORIGINAL SIZE."
IT WAS REPORTED THAT 3 UNSPECIFIED BD¿ LUER-SLIP SYRINGES HAD ISSUES WITH DAMAGED LUERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "THREE RECORDS OF NON-COMPLIANCE REGARDING 3 ML LUER SLIP SYRINGES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2683512 | BD PLASTIPAK¿ 3-PIECE SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON IND. CIRURGICAS LTDA | 1179054 | 07891463002655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |