BD CANNULA INTERLINK THREADED LOCK
Report
- Report Number
- 1213809-2022-00025
- Event Type
- Malfunction
- Date Received
- January 31, 2022
- Date of Event
- December 27, 2021
- Report Date
- February 16, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 00382903033690
- PMA / PMN Number
- K011858
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-04. H6: INVESTIGATION SUMMARY: FOUR PICTURES AND ONE SAMPLE OF A THREAD LOCK COMPONENT (P/N 303369) FROM BATCH # 1082816 WERE RECEIVED AND EVALUATED. NO BLOCKAGE OBSERVED FROM PHOTOS AND PHYSICAL SAMPLE RECEIVED. SINCE THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED WHEN USING THE BD CANNULA INTERLINK THREADED LOCK, THE DEVICE EXPERIENCED FLOW ISSUES. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT A FLOW ISSUE. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE HCP CONNECTED A THREADED LOCK CANNULA TO THE INJECTION SITE OF A2N3374-ZBA BUT THE FLUID DIDN'T FLOW. THE HCP THEN USED ANOTHER THREADED LOCK CANNULA BUT THE FLUID STILL DIDN¿T FLOW.
IT WAS REPORTED WHEN USING THE BD CANNULA INTERLINK THREADED LOCK, THE DEVICE EXPERIENCED FLOW ISSUES. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT A FLOW ISSUE. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE HCP CONNECTED A THREADED LOCK CANNULA TO THE INJECTION SITE OF A2N3374-ZBA BUT THE FLUID DIDN'T FLOW. THE HCP THEN USED ANOTHER THREADED LOCK CANNULA BUT THE FLUID STILL DIDN¿T FLOW.
IT WAS REPORTED WHEN USING THE BD CANNULA INTERLINK THREADED LOCK, THE DEVICE EXPERIENCED FLOW ISSUES. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT A FLOW ISSUE. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE HCP CONNECTED A THREADED LOCK CANNULA TO THE INJECTION SITE OF A2N3374-ZBA BUT THE FLUID DIDN'T FLOW. THE HCP THEN USED ANOTHER THREADED LOCK CANNULA BUT THE FLUID STILL DIDN¿T FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1736372 | BD CANNULA INTERLINK THREADED LOCK | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 1082816 | 00382903033690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |