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

Model Number 381834

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2021

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.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in was damaged.This occurred on 6 occasions.The following information was provided by the initial reporter: some catheter were cracked by unknown accident.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in was damaged.This occurred on 6 occasions.The following information was provided by the initial reporter: some catheter were cracked by unknown accident.

Manufacturer Narrative

H6: investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received six units within packaging and three photos.Upon inspection of the photos and the returned units, it was found that multiple packages had been torn and the needle covers had been damaged on multiple units.The reported defect was confirmed.Damage to sealed packages may occur during the packaging process but may also occur during shipping and handling of the product.Bd was unable to confirm which scenario was more likely.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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12702912
• MDR Text Key: 278574074
• Report Number: 1710034-2021-00916
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 1089066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1