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

Catalog Number 381033

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use of the bd insyte autoguard bc shielded iv catheter there was cotton like foreign matter on the catheter tip.

Event Description

It was reported that before use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was cotton like foreign matter on the catheter tip.

Manufacturer Narrative

Investigation summary: dhr: although the review of the dhrs review are required for mdr¿s per ms-qs-083, a review could not be performed as the lot number was not provided.Received one unused iag bc 20ga catheter/adapter assembly and a needle cover from catalog number 381033 and lot number unknown.Two photos were submitted for review.Visual/microscopic evaluation: white particulate was present at the tip of the catheter tubing.The particulate was identified to be non-foreign (porous plug shavings); the porous plug shavings (non-foreign) exceeded 0.2 square millimeters measured per tappi dirt estimation chart.Photos: based on the evaluation of the submitted photos; two of the photos displayed white particulate on the catheter tubing.Which is the same finding as that of the evaluation of the returned unit.Probable root cause: manufacturing process: the white particulate was confirmed to be non-foreign (porous plug shavings) resulting from manufacturing process.The white particulate can be loosely attached to the catheter tubing due to the silicone lube.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8347505
• MDR Text Key: 136507488
• Report Number: 1710034-2019-00178
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other