BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
Report
- Report Number
- 2243072-2023-01936
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- October 18, 2023
- Report Date
- July 24, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- JKA
- UDI-DI
- 00382903672813
- PMA / PMN Number
- K991088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE CATALOG #: 367296. D4. MEDICAL DEVICE LOT#: 2K1381. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2025. D4: UDI #: (B)(4). G.5. PMA / 510(K)#: K980414. H4. DEVICE MANUFACTURE DATE: 31-DEC-2022.
UNKNOWN MANUFACTURER: 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. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE CATALOG #: 367281. D4. MEDICAL DEVICE LOT#: 23E1511. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. D4: UDI #: (B)(4). G.5. PMA / 510(K)#: K991088. H4. DEVICE MANUFACTURE DATE: 26-AUG-2023.
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 6 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND TWO DEVICE SKU'S ARE SEEN, THE MENTIONED CORRECT PRODUCT (367281; LOT 23E1511) AND THE MENTIONED INCORRECT PRODUCT (367296; 2K1381). LOT 23E1511 OF SKU 367281 WAS PACKED IN MAY 2023. LOT 2K1381 OF SKU 367296 WAS PACKED IN OCTOBER 2022. THESE TWO LOTS WERE PACKED ON DIFFERENT PACKING MACHINES AT DIFFERENT BUILDINGS. THIS MAKES IT IMPOSSIBLE FOR THE TWO SKU'S SEEN IN THE PHOTOS TO BE MIXED DURING THE MANUFACTURING PROCESS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE MIXED PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE A MIX OF PRODUCT TYPES IN ONE BOX. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS AS RECEIVED 367281 MIXED WITH 367926 IN SAME BOX."
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE A MIX OF PRODUCT TYPES IN ONE BOX. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS AS RECEIVED 367281 MIXED WITH 367926 IN SAME BOX."
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE A MIX OF PRODUCT TYPES IN ONE BOX. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS AS RECEIVED 367281 MIXED WITH 367926 IN SAME BOX."
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THERE A MIX OF PRODUCT TYPES IN ONE BOX. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS AS RECEIVED 367281 MIXED WITH 367926 IN SAME BOX."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1567226 | BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON | 23E1511 | 00382903672813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |