BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2024-01078
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- October 24, 2024
- Report Date
- January 6, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 30382903678410
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY . MATERIAL #: 367841. LOT/BATCH #: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 4045109 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025 H4. DEVICE MANUFACTURE DATE: 14-FEB-2024 D.4 UDI#: (B)(6). D2B: MEDICAL DEVICE TYPE: JKA THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: BK230980, K213670, AND K231373. H.6 IMDRF ANNEX C GRID (1): C19 - NO DEVICE PROBLEM FOUND INVESTIGATION SUMMARY BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND ALL HEMOGARD CLOSURE ASSEMBLIES WERE CORRECTLY ASSEMBLED AND PLACED ON THE TUBES WITH NO ISSUES IDENTIFIED. ADDITIONALLY, 10 RETAINED SAMPLES UNDERWENT FUNCTIONAL TESTS, WITH ALL RESULTS BEING WITHIN SPECIFICATION LIMITS. NO ISSUES WERE IDENTIFIED WITH THE HEMOGARD CLOSURE ASSEMBLIES BEING LOOSE OR SEPARATING FROM THE TUBES DURING OR AFTER TESTING. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: STOPPER FUNCTION. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
D2B. MEDICAL DEVICE TYPE: THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K213670, K231373. H.4. 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.
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THAT THE STOPPERS WERE POPPING OFF. THIS OCCURRED ON AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THAT THE STOPPERS WERE POPPING OFF. THIS OCCURRED ON AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THAT THE STOPPERS WERE POPPING OFF. THIS OCCURRED ON AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334414 | BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 4045109 | 30382903678410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |