BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN
Report
- Report Number
- 1710034-2020-00108
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Date of Event
- December 28, 2019
- Report Date
- March 2, 2020
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835110
- PMA / PMN Number
- K183399
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10
IT WAS REPORTED THAT 8 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS¿ SINGLE PORT 24 GA 0.75 IN EXPERIENCED DEVICE DAMAGE/DEFECTIVE -DEVICES STILL OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 9260434. PER EMAIL: WE WOULD LIKE TO BRING TO YOUR ATTENTION A COMPLAINT THAT WE RECEIVED ON ONE OF YOUR PRODUCTS : PRODUCT NUMBER : 383511. DESCRIPTION : CLOSED IV CATHETER NEXIVA¿ 24 GAUGE 3/4 INCH SLIDING SAFETY NEEDLE LOT NUMBER : 9260434. QUANTITY : (B)(4). DETAILS OF THE COMPLAINT THE POINT OF THE NEEDLE TEARS THE SKIN OF THE PATIENTS. AS IT IS IMPOSSIBLE TO MAKE THE INJECTION, THE CATHETER MUST BE CHANGED. HERE ARE MORE DETAILS ABOUT THE COMPLAINT: WHAT WAS THE DATE THE INCIDENT OCCURRED? (B)(6)2019. WAS ANY MEDICAL INTERVENTION OR OTHER ACTIONS TAKEN AS A RESULT? USE OF ANOTHER CATHETER WHICH HAS TO BE INSERTED TO THE PATIENT AGAIN. IS A SAMPLE AVAILABLE TO RETURN FOR EVALUATION? YES. IF SO, DO YOU HAVE A CONTAINER TO RETURN THE PRODUCT SAFELY? IF NOT, BD CAN PROVIDE ONE FOR YOU. YES, WE HAVE A CONTAINER. LET US KNOW IF YOU HAVE ANY QUESTION.
OCCUPATION: QUALITY ASSURANCE REGULATORY AFFAIRS ASSOCIATE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT 8 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS¿ SINGLE PORT 24 GA 0.75 IN EXPERIENCED DEVICE DAMAGE/DEFECTIVE -DEVICES STILL OPERABLE. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 , BATCH NO.: 9260434. PER EMAIL: WE WOULD LIKE TO BRING TO YOUR ATTENTION A COMPLAINT THAT WE RECEIVED ON ONE OF YOUR PRODUCTS : PRODUCT NUMBER : 383511, DESCRIPTION : CLOSED IV CATHETER NEXIVA¿ 24 GAUGE 3/4 INCH SLIDING SAFETY NEEDLE, LOT NUMBER : 9260434, QUANTITY : 8 UNITS. DETAILS OF THE COMPLAINT THE POINT OF THE NEEDLE TEARS THE SKIN OF THE PATIENTS. AS IT IS IMPOSSIBLE TO MAKE THE INJECTION, THE CATHETER MUST BE CHANGED. HERE ARE MORE DETAILS ABOUT THE COMPLAINT: WHAT WAS THE DATE THE INCIDENT OCCURRED? (B)(6) 2019. WAS ANY MEDICAL INTERVENTION OR OTHER ACTIONS TAKEN AS A RESULT? USE OF ANOTHER CATHETER WHICH HAS TO BE INSERTED TO THE PATIENT AGAIN. IS A SAMPLE AVAILABLE TO RETURN FOR EVALUATION? YES. IF SO, DO YOU HAVE A CONTAINER TO RETURN THE PRODUCT SAFELY? IF NOT, BD CAN PROVIDE ONE FOR YOU. YES, WE HAVE A CONTAINER. LET US KNOW IF YOU HAVE ANY QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211537 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 383511 | 9260434 | 30382903835110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |