MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382544

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: material no.: 382544, batch no.: 0198337.Just wanted to bring to your attention the issue we are having with the bd iv catheters.This was the second reported, but they saved it for me this time! the safety mechanism to retract the needle would not work.18g x1.16 inch (last time was a 20g) exp 2023-06-30.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: material no: 382544 batch no: 0198337 just wanted to bring to your attention the issue we are having with the bd iv catheters.This was the second reported, but they saved it for me this time! the safety mechanism to retract the needle would not work.18g x1.16 inch (last time was a 20g) exp 2023-06-30.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11098379
• MDR Text Key: 226019716
• Report Number: 1710034-2020-00841
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: 00382903825448
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: 06/30/2023
• Device Catalogue Number: 382544
• Device Lot Number: 0198337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1