BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2022-00073
- Event Type
- Malfunction
- Date Received
- March 25, 2022
- Date of Event
- March 2, 2022
- Report Date
- May 2, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE LOT NUMBER INDICATED ON THE OUTER BOX LABEL IS: MEDICAL DEVICE LOT #: 1167149, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2022, DEVICE MANUFACTURE DATE: 16-JUN-2021. THE INFORMATION FOR THE LOT NUMBER INCORRECTLY INCLUDED IN THIS BOX IS: MEDICAL DEVICE LOT #: 1132352, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2022, DEVICE MANUFACTURE DATE: 12-MAY-2021. INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED THEY RECEIVED 3 CLOSED BOXES WITH 50EA AND ONE OPEN WITH 38 VIALS. INSIDE A BOX OF BATCH 1167149 EXP. DATE 03/31/2022 THERE WERE (B)(4) UNITS OF BATCH 1132352 EXPIRATION DATE 02/28/2022. THREE PHOTOS WERE RECEIVED. ONE OF THE PHOTOS HAD PLASTIC CLEAR TAPE IN THE OUTSIDE OF THE BOX. CARTON CASES FOR PLASTIC PRODUCT DOES NOT REQUIRED THE USE OF CLEAR PLASTIC TAPE TO SEAL THE CASE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. CONTROLS IN PLACE ARE THE FOLLOWING: LABELING OPERATION SHIFT LEADER MUST ENSURE THAT THE BATCH NUMBER IN THE BATCH CONTROL RECORD (BCR) IS THE SAME AS THE BATCH NUMBER OF THE BOTTLES CARTS TO BE LABELED. INSPECTIONS ARE PERFORMED TO REMOVE OBVIOUS DEFECTS, INCLUDING CAP SEAL DEFECTS (I.E. CAP SEAL AND COLOR). PROCESS CONTROL TECHNICIAN PERFORMS INSPECTIONS FOR CORRECT BATCH NUMBERS, EXPIRATION DATES, CASE COMPLETENESS, CASE DAMAGE, LEGIBLE CARTON AND LABEL BATCH INFORMATION. COMPLAINT IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT 12 OF THE 50 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) RECEIVED BY THE CUSTOMER HAD A DIFFERENT LOT NUMBER THAN WAS INDICATED BY THE BOX LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAME WAS SENT TO OUR CUSTOMER IN A CLOSED BOX WITH 50 UNITS, AND, WHEN IT WAS USED, HE NOTICED THAT THERE WERE 12 BOTTLES WITH BATCH AND VALIDITY DIFFERENT FROM THE BOX LABEL.
IT WAS REPORTED THAT 12 OF THE 50 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) RECEIVED BY THE CUSTOMER HAD A DIFFERENT LOT NUMBER THAN WAS INDICATED BY THE BOX LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAME WAS SENT TO OUR CUSTOMER IN A CLOSED BOX WITH (B)(4) UNITS, AND, WHEN IT WAS USED, HE NOTICED THAT THERE WERE 12 BOTTLES WITH BATCH AND VALIDITY DIFFERENT FROM THE BOX LABEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009535 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442023 | SEE H10 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |