BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Report
- Report Number
- 1024879-2023-00800
- Event Type
- Malfunction
- Date Received
- November 8, 2023
- Date of Event
- October 21, 2023
- Report Date
- February 29, 2024
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FPA
- UDI-DI
- 50382903673648
- PMA / PMN Number
- K212724
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 29-NOV-2023. H.6. INVESTIGATION SUMMARY: "MATERIAL #: 367364. LOT/BATCH #: 2241223. BD RECEIVED 1 SAMPLE AND 1 PHOTO FOR INVESTIGATION. THE SAMPLE AND PHOTO WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. THE FOREIGN MATERIAL FROM THE CUSTOMER SAMPLE WAS ANALYZED WITH FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND IT WAS DETERMINED TO BE A FIBROUS MATERIAL, LIKELY CORRUGATED CARDBOARD. ADDITIONALLY, 30 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. 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."
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.2. MEDICAL DEVICE TYPE: JKA H.6. INVESTIGATION SUMMARY: MATERIAL #: 367364 LOT/BATCH #: 2241223. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 30 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. 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 HAS BEEN REPORTED THAT THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAS BEEN FOUND CONTAINING FOREIGN MATTER. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT FOREIGN MATTER INSIDE THE NEEDLE CAP.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAS BEEN FOUND CONTAINING FOREIGN MATTER. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT FOREIGN MATTER INSIDE THE NEEDLE CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744477 | BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | FPA | BECTON, DICKINSON & CO., (BD) | 2241223 | 50382903673648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |