MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC WING PNK 20GA X1.16IN; INTRAVASCULAR CATHETER

Catalog Number 382634

Device Problem Defective Component (2292)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility: (b)(6).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 wing pnk 20ga x1.16in needle went through the catheter.The following information was provided by the initial reporter: it was reported the end of the iv catheter didn't look quite right.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed cannulas piercing through the catheter tubing.The reported issue was confirmed.Catheter tubing can become pierced during use, or through misalignment of machinery during manufacture.Due to the inability to review the affected device our engineers were not able to determine the root cause for this event at this time.This is the only known occurrence of this issue being reported for this manufacturing lot, and a device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that insyte autog bc wing pnk 20ga x1.16in needle went through the catheter.The following information was provided by the initial reporter: it was reported the end of the iv catheter didn't look quite right.

• Brand Name: INSYTE AUTOG BC WING PNK 20GA X1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12005953
• MDR Text Key: 261935108
• Report Number: 1710034-2021-00498
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: 00382903826346
• 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: 07/07/2021

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: 05/31/2022
• Device Catalogue Number: 382634
• Device Lot Number: 9170992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1