MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number 381834

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in was damaged.The following information was provided by the initial reporter: hole in the mandrel.

Manufacturer Narrative

Investigation summary a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0161815, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in was damaged.The following information was provided by the initial reporter: hole in the mandrel.

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10988815
• MDR Text Key: 221286690
• Report Number: 9610048-2020-00173
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 381834
• Device Catalogue Number: 38183414
• Device Lot Number: 0161815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1