MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED GRAY 16GA X 1.16; INTRAVASCULAR CATHETER

Catalog Number 381554

Device Problem Retraction Problem (1536)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard winged gray 16ga x 1.16 experienced needle retraction failure.The following information was provided via medwatch the needle did not retract when i hit this button to activate the safety.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.E4.The initial reporter also notified the fda on october of 2023.Medwatch report is 2300530000-2023-8032.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.The dhr for lot 3142650 has been reviewed.Subassembly lot 3142650 material 700iagw44 was built on afa line 6 from 06jun2023 through 09jun2023.Final lot was packaged on pkg line 10 from 10jun2023 through 11jun2023 for a total quantity of (b)(4).No related quality issues or process deviations were found.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD WINGED GRAY 16GA X 1.16
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18832550
• MDR Text Key: 337702459
• Report Number: 1710034-2024-00156
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815548
• UDI-Public: (01)00382903815548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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: Health Professional
• Device Catalogue Number: 381554
• Device Lot Number: 3142650
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1