BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2022-00170
- Event Type
- Malfunction
- Date Received
- March 25, 2022
- Date of Event
- March 15, 2022
- Report Date
- August 26, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- JKA
- PMA / PMN Number
- K991088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. 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. THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECT INFORMATION: MDR OWNERSHIP SITE LEGAL NAME: FRANKLIN LAKES NJ, D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON FRANKLIN LAKES. D.4. MEDICAL DEVICE LOT # : 0D2211. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . G.1. MANUFACTURING LOCATION: BECTON DICKINSON FRANKLIN LAKES. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING INFORMATION WAS NOT PROVIDED PREVIOUSLY: FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS NIPRO IS AN OEM MANUFACTURING SITE. H.6. INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 8 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO HUB - HOLDER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. ANOTHER 25 RETENTION SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO HUB - HOLDER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. 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 HUB - HOLDER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS THERE WAS NEEDLE AND HOLDER SEPARATE/SPIN OUT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PERFORMING VENIPUNCTURE USING SLBCS WITH PRE-ATTACHED HOLDER, THE HOLDER DETACHED FROM THE NEEDLE 3 TIMES. THE LUER ADAPTER WAS DESCRIBED AS "POPPING OFF"."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS THERE WAS NEEDLE AND HOLDER SEPARATE/SPIN OUT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PERFORMING VENIPUNCTURE USING SLBCS WITH PRE-ATTACHED HOLDER, THE HOLDER DETACHED FROM THE NEEDLE 3 TIMES. THE LUER ADAPTER WAS DESCRIBED AS "POPPING OFF"."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS THERE WAS NEEDLE AND HOLDER SEPARATE/SPIN OUT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PERFORMING VENIPUNCTURE USING SLBCS WITH PRE-ATTACHED HOLDER, THE HOLDER DETACHED FROM THE NEEDLE 3 TIMES. THE LUER ADAPTER WAS DESCRIBED AS "POPPING OFF"."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851211 | BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON | 0D2211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |