BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Report
- Report Number
- 2618282-2019-00237
- Event Type
- Malfunction
- Date Received
- August 12, 2019
- Date of Event
- July 26, 2019
- Report Date
- September 4, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903649020
- PMA / PMN Number
- K030573
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: THE CATALOG AND LOT NUMBERS HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN CORRECTED: B.4. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT CLOT THE BLOOD PROPERLY DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN.THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES ARE NOT CLOTTING THE BLOOD PROPERLY." D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET D.2. MEDICAL DEVICE TYPE: FPA. D.2. MEDICAL DEVICE CATALOG#: 367344. D.2. MEDICAL DEVICE LOT#: 8010742. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD). D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD). G.5. PMA / 510(K)#: K030573. H.4. DEVICE MANUFACTURE DATE: 2018-01-10.
INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.
IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT CLOT THE BLOOD PROPERLY DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN.THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES ARE NOT CLOTTING THE BLOOD PROPERLY."
IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT CLOT THE BLOOD PROPERLY DURING USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES ARE NOT CLOTTING THE BLOOD PROPERLY."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.
IT WAS REPORTED THAT 2 SEPARATE BD LUER-LOK ACCESS DEVICES DID NOT CLOT THEIR BLOOD PROPERLY DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES ARE NOT CLOTTING THE BLOOD PROPERLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679119 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 8010742 | 00382903649020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |