INSYTE AUTOGUARD BL 22GA X 1.0IN
Report
- Report Number
- 1710034-2024-01357
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- October 31, 2024
- Report Date
- June 16, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903814237
- PMA / PMN Number
- K201075
- Removal / Correction Number
- MDS-25-5274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. ADDITIONAL BATCH REPORTED: BATCH: 4212199, BATCH CREATION DATE: 2024-08-05, BATCH EXPIRATION DATE: 2027-07-31, FULL UDI: (B)(4).
INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WAS NOT RETRACTING AND THAT THE CATHETER WAS SPLIT COULD NOT BE RETURNED FROM THE UNUSED REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOTS 4212199 AND 4229661. A FUNCTIONAL TEST AND MICROSCOPIC EXAMINATION REVEALED NO DAMAGE OR DEFECTS ON THE RETURNED SAMPLES. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.
ADDITIONAL INFORMATION OF FA #.
CORRECTION OF TYPO IN INVESTIGATION SUMMARY: THE COMPLAINT THAT THE NEEDLE WAS NOT RETRACTING AND THAT THE CATHETER WAS SPLIT COULD NOT BE CONFIRMED FROM THE UNUSED REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOTS 4212199 AND 4229661. A FUNCTIONAL TEST AND MICROSCOPIC EXAMINATION REVEALED NO DAMAGE OR DEFECTS ON THE RETURNED SAMPLES. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.
MATERIAL # 381423, BATCH # 4212199, 4229661. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE NOT RETRACTING AND THE TIP OF THE CATHETER IS SPLIT. VERBATIM: MAT# 381423 LOT# 4212199,4229661 THE NEEDLE NOT RETRACTING AND THE TIP OF THE CATHETER IS SPLIT, CUSTOMER HAS SAMPLES TO SEND. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? REPORTS FROM SEVERAL NURSES STATING THEY INSPECTED THE CATHETER PRIOR TO USE AND THEY LOOK NORMAL, BUT WHEN USED THEY TIP OF THE CATHETER IS SPLIT AND THE PATIENT EXPERIENCES A LOT OF PAIN. WHEN ATTEMPTING TO RETRACT THE NEEDLE, IT WILL NOT RETRACT UNTIL THE BUTTON IS PRESSED SEVERAL TIMES. WAS BOT THE ISSUES "NEEDLE NOT RETRACTING AND THE TIP OF THE CATHETER IS SPLIT" OCCURRED ON BOTH LOT# 4212199 & 4229661? YES, BOTH LOT NUMBERS. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE WHAT WAS THE IMPACT TO THE PATIENT? THE PATIENTS HAVE HAD BLOWN VEINS AND COMPLAIN OF A LOT OF PAIN. ALSO, THEY HAVE TO GET STUCK SEVERAL TIMES. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO SERIOUS INJURY, BUT THE DOCTORS HAVE BEEN MADE AWARE OF THE DEFECTS. THEY ARE CONCERNED ABOUT CORRECTIVE ACTION AND COST WHEN WE HAVE TO USE SEVERAL PER PATIENT.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334415 | INSYTE AUTOGUARD BL 22GA X 1.0IN | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON DICKINSON | 4229661 | 00382903814237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |