BD INSYTE AUTOGUARD
Report
- Report Number
- 9610048-2024-00213
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 18, 2024
- Report Date
- June 9, 2025
- Manufacturer
- BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
- Product Code
- FOZ
- UDI-DI
- 00382903818129
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED. UPDATED B. AND F CODE.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38181214 AND LOT NUMBERS 3270548, 4122892, AND 4092056. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE AND SAMPLE AND TEN (10) PHYSICAL SAMPLES BELONGING TO LOT NUMBER 4092056 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE WAS SHOWN PROTRUDING THROUGH THE CATHETER AND THE PRODUCT WAS USED. IT IS WORTH NOTING THAT IF THE PRODUCT WERE TRANSFIXED DUE TO A MANUFACTURING ISSUE, IT WOULD NOT BE POSSIBLE TO USE THE PRODUCT. THE TEN (10) UNUSED SAMPLES WERE RECEIVED IN SEALED PACKAGES. THROUGH INSPECTION OF THE PHYSICAL SAMPLES, NO DAMAGES OR DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, IT IS MOST LIKELY THAT THIS INCIDENT RESULTED FROM THE USE OF THE PRODUCT. WHEN PERFORMING THE 360-DEGREE ROTATION DURING PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD RESULTING IN A TRANSFIXED CATHETER DURING PUNCTURE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. ADDITIONAL LOT NUMBERS WERE PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 38181214. LOT # 3270548 MNF DATE 2023-10-04 EXP DATE 2026-09-30 AND LOT # 4122892 MNF DATE 2024-05-17 EXP DATE 2027-04-30.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38181214 AND LOT NUMBERS 3270548, 4122892, 4092056. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE WAS OBSERVED THROUGH THE CATHETER AND USED. IT IS WORTH NOTING THAT IF THE PRODUCT WERE TRANSFIXED DUE TO A MANUFACTURING ISSUE, IT WOULD NOT BE POSSIBLE TO USE THE PRODUCT. BASED ON THE INVESTIGATION RESULTS, IT IS MOST LIKELY THAT THIS INCIDENT RESULTED FROM THE USE OF THE PRODUCT. WHEN PERFORMING THE 360-DEGREE ROTATION DURING PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD RESULTING IN A TRANSFIXED CATHETER DURING PUNCTURE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
ADDITIONAL INFORMATION RECEIVED ON JANUARY 06, 2025. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? YES, ALL PATIENTS PUNCTURED WITH THE MATERIAL HAD TO BE PUNCTURED MORE THAN ONCE BECAUSE OF THE QUALITY OF THE ABOCATH. DID THE REPORTED EVENT OCCUR IN ALL 3 BATCHES? YES.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CUSTOMER REPORT: MATERIAL HAS A PROBLEM WITH THE TIP OF THE CATHETER, AS SHOWN IN THE ATTACHED IMAGE. CUSTOMER HAS MATERIAL IN QUARANTINE AND WISHES TO RETURN IT. I HEREBY REVIEW A POSSIBLE QUALITY DEVIATION IN THE PRODUCT: INSYTE AUTOGUARD N. 24GAX0,75 C/50-SECURITY (38181214). LOT 3270548- (B)(4) UNITS - NFO: (B)(4). LOT: 4122892- (B)(4) UNITS - NFO: (B)(4). LOT: 4092056- (B)(4) UNITS - NFO: (B)(4).
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359806 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. | 4092056 | 00382903818129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |