INSYTE
Report
- Report Number
- 9610048-2025-00169
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- October 1, 2025
- Report Date
- January 28, 2026
- Manufacturer
- BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831414 AND LOT NUMBER 5113038. 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, A SAMPLE SHIPMENT WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. HOWEVER, THE SAMPLE SHIPMENT CONTAINED ONLY A UNIT PACKAGE, WITHOUT THE INSYTE PRODUCT. THE UNIT PACKAGE CONFIRMED THE MATERIAL INFORMATION (MATERIAL NUMBER 38831414 AND LOT NUMBER 5113038). WITHOUT THE PRODUCT SAMPLE, IT WAS NOT POSSIBLE TO IDENTIFY ANY DEFECTS OR PERFORM ANY TESTS. BASED ON THE INVESTIGATION RESULTS SO FAR, A PROBABLE ROOT CAUSE MAY BE RELATED TO A BURR ON THE ADAPTER THAT PREVENTED PROPER FITTING AND THREADING ACCORDING TO THE PRODUCT DESIGN. HOWEVER, DURING THE ANALYSIS, NO RECORDS WERE FOUND IN THE BATCH HISTORY THAT COULD CONFIRM THE REPORTED DEFECT OR A MANUFACTURING RELATED CAUSE. 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.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831414 AND LOT NUMBER 5113038. 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. AS NEITHER PICTURE NOR PHYSICAL SAMPLES WERE RECEIVED, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS SO FAR, A PROBABLE ROOT CAUSE MAY BE RELATED TO A BURR ON THE ADAPTER THAT PREVENTED PROPER FITTING AND THREADING ACCORDING TO THE PRODUCT DESIGN. HOWEVER, DURING THE ANALYSIS, NO RECORDS WERE FOUND IN THE PRODUCTION HISTORY THAT COULD JUSTIFY THE REPORTED DEFECT. 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.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT CATHETER NO. 20 WAS DEFECTIVE. DESCRIPTION OF DEVIATION: IT WAS REPORTED THAT DURING PREPARATION FOR VENIPUNCTURE, IT WAS IDENTIFIED THAT THE DEVICE HAD A MANUFACTURING DEFECT, MAKING IT IMPOSSIBLE TO USE PROPERLY. THE PROBLEM WAS DETECTED BEFORE USE, DURING THE INITIAL VISUAL INSPECTION OF THE PRODUCT. TECHNICAL ANALYSIS: THE PRODUCT PRESENTED STRUCTURAL NON-COMPLIANCE, COMPROMISING ITS INTEGRITY AND THE SAFETY OF THE PROCEDURE. CONSIDERING THAT THERE WERE NO FAILURES IN STORAGE OR HANDLING AT THE SITE, IT IS ASSUMED THAT THE DEFECT ORIGINATED AT THE FACTORY. THE PRODUCT WAS IMMEDIATELY SEGREGATED AND REPLACED, WITHOUT CAUSING HARM TO THE PATIENT OR COMPROMISING CARE. CONCLUSION: IT IS CONCLUDED THAT THE INCIDENT WAS A QUALITY DEVIATION DUE TO A MANUFACTURING DEFECT IN THE INSYTE CATHETER NO. 20G, BD BRAND, LOT 5113038, EXPIRY DATE 04/2030. WERE OTHER MEASURES TAKEN AFTER THE PROBLEM WAS IDENTIFIED? YES - REPLACED WITH ADDITIONAL CATHETER ADD INFO RECEIVED ON 30 OCT 2025 COULD YOU EXPLAIN IN DETAIL WHAT TYPE OF MANUFACTURING DEFECT WAS IDENTIFIED IN THE PRODUCT? WHEN ATTACHING THE POLYFIX, IT DOES NOT CONNECT PROPERLY AND LEAKS. ADD INFO RECEIVED ON 07 NOV 2025 1. PLEASE CLARIFY WHEN THE REPORTED INCIDENT OCCURRED? BEFORE OR AFTER USE? DURING USE, IT IS ALREADY APPARENT THAT IT DOES NOT FIT PROPERLY AND CONTINUES TO LEAK. 2. PLEASE CONFIRM IF ANY PATIENTS WERE AFFECTED? IF SO, PLEASE SHARE DETAILS OF THE DAMAGE AND MEDICAL INTERVENTION, IF ANY? I SEE THAT THE ONLY PROBLEM IS THAT SOMETIMES THE PUNCTURE HAD TO BE REDONE AND THE CATHETER REPLACED BECAUSE IT DID NOT FIT CORRECTLY AND KEPT LEAKING. 3. PLEASE CONFIRM WHETHER THE LEAK IS DUE TO A CONNECTION PROBLEM. I BELIEVE IT IS A DEFECT IN THE CATHETER. 4. PLEASE CONFIRM THE EXACT LOCATION OF THE OBSERVED LEAK? AT THE POINT WHERE THE TWO-WAY EQUIPMENT IS CONNECTED. 5. PLEASE CONFIRM WHETHER ANY PHYSICAL DAMAGE OR DEFORMATION WAS OBSERVED IN THE CONNECTION AND IN THE AREA OF THE LEAK? NO, I BELIEVE IT IS A DEFECT IN THE CATHETER.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198916 | INSYTE | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. | 5113038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |