BD PRESET¿
Report
- Report Number
- 9617032-2021-01420
- Event Type
- Malfunction
- Date Received
- January 13, 2022
- Date of Event
- December 22, 2021
- Report Date
- January 31, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- K022426
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 HAS BEEN PROVIDED TO CAPTURE THE CORRECT CATALOG NUMBER : 364316. B.5. DESCRIBE EVENT OF PROBLEM: IT WAS REPORTED WHEN USING THE BD PRESET¿ , THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, FM WAS FOUND INSIDE THE SYRINGE. D.1: BRAND NAME: BD PRESET¿ D.3. MANUFACTURER NAME, CITY AND STATE: BECTON, DICKINSON AND COMPANY (BD) D.4. CATALOG #:364316 D.4. LOT #: 0331026 D.4. EXPIRATION DATE: 2022-12-31 G.6. 510K: K022426 H.4. DEVICE MANUFACTURE DATE: 2020-11-26
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/8/2022. H.6. INVESTIGATION: BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. A PIECE OF TRANSLUCENT PLASTIC WAS FOUND INSIDE THE BARREL OF THE SYRINGE WHICH LOOKS TO BE PART OF THE TOP OF A PLUNGER ROD. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED WHEN USING THE BD PRESET¿ ECLIPSE¿ , THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, FM WAS FOUND INSIDE THE SYRINGE.
IT WAS REPORTED WHEN USING THE BD PRESET¿ , THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, FM WAS FOUND INSIDE THE SYRINGE.
IT WAS REPORTED WHEN USING THE BD PRESET¿ , THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, FM WAS FOUND INSIDE THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660946 | BD PRESET¿ | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 0331026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |