MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 382533

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/16/2021

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 autog bc pnk 20ga x 1.0in was partially retracted and the employee was stuck with the needle.The following information was provided by the initial reporter: material no:382533, batch no: 0307311.It was reported that the employee was stuck with the needle on two separate occasions.Verbatim: our customer has reported 1st incident was (b)(6) and employee was stuck with the needle.Employee did take picture of iv catheter but then disposed of the cath.Management pulled from the same lot and tried to recreate the issue with no success.2nd incident (b)(6) and the exact same thing happened again, this time no injury involved.

Event Description

It was reported that insyte autog bc pnk 20ga x 1.0in was partially retracted and the employee was stuck with the needle.The following information was provided by the initial reporter: material no: 382533, batch no: 0307311.It was reported that the employee was stuck with the needle on two separate occasions.Our customer has reported 1st incident was on (b)(6) and employee was stuck with the needle.Employee did take picture of iv catheter but then disposed of the cath.Management pulled from the same lot and tried to recreate the issue with no success.2nd incident on (b)(6) and the exact same thing happened again, this time no injury involved.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo.Visual observation of the photo revealed the needle was only partially retracted which would allow for a needle stick injury to occur, confirming the reported defect.This defect is most likely related to the manufacturing process but without examining the actual device, a specific root cause could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: INSYTE AUTOG BC PNK 20GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11586669
• MDR Text Key: 242897192
• Report Number: 1710034-2021-00253
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: 00382903825332
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 04/19/2021

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: 10/31/2023
• Device Catalogue Number: 382533
• Device Lot Number: 0307311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1