MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number 381834

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

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 needle was stuck in the cap.The following information was provided by the initial reporter: the inner cannula stuck in the cap.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in needle was stuck in the cap.The following information was provided by the initial reporter: the inner cannula stuck in the cap.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/22/2020.H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one retracted unit with the catheter adapter assembly inside the needle cover and one photo.During the visual examination it was observed that the push tab was misaligned by ninety degrees.A microscopic inspection of the catheter adapter and needle cover was performed.Inside the needle cover, one of the ribs was found to be significantly deformed along with some damage to the top of the adapter threads.This was physical/mechanical evidence to confirm and support a manufacturing equipment/process related issue for the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11122151
• MDR Text Key: 227545492
• Report Number: 1710034-2021-00004
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 0132400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1