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

Model Number 381823

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

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¿ shielded iv catheter experienced foreign matter contamination.The following information was provided by the initial reporter: a black spot is on the cannula.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/5/2021.H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one photograph which displayed a circle around a black dot on the catheter or needle cover.One retracted unit along with the catheter, needle cover, and opened package were also received.Upon inspection of the device, it was found that a black speck was present on the catheter tubing.The foreign matter was microscopically inspected where it was observed that the foreign appears to be imbedded in the surface of the catheter tubing or covered in silicon lubrication.Upon scraping the foreign matter, it was found that the foreign matter was only covered by silicon lubrication.Based on the visual and microscopic evaluation of the foreign matter an origin could not be determined.The unit was sent for further testing.The results confirmed the foreign matter to be poly(ester urethane).Although the defect was confirmed, a specific root cause could not be determined.However, as the foreign was found underneath the layer of silicon lube it was most likely introduced prior to the lubrication process.Based on the historical data, the defect is uncommon and is considered incidental.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced foreign matter contamination.The following information was provided by the initial reporter: a black spot is on the cannula.

• Brand Name: BD INSYTE AUTOGUARD 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: 11162959
• MDR Text Key: 227077498
• Report Number: 1710034-2021-00022
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 381823
• Device Catalogue Number: 381823
• Device Lot Number: 0149900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1