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

Catalog Number 381023

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

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

Event Date 10/07/2021

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.

Event Description

It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter there was foreign matter on the needle cover.The following information was provided by the initial reporter.The customer stated: "dirt was found on the needle cover.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received sixteen unopened units and one opened unit for investigation.In addition, eight photos were received for investigation.Upon inspection of the customer photos and the received units, foreign matter was only observed on the opened unit.The foreign matter was observed on the inside of the needle, on the button, on the catheter tubing, and on the needle tip.Based on the microscopic inspection the identity of the material could not be determined.Further spectral analysis identified the black material observed on the sample as catheter material.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.Possible introduction of small catheter material may occur when cutting the catheter to length, catheter tipping, or from skiving during placement over the needle.Due to the black coloring of the foreign matter and it being catheter tubing the most likely source is tipping as this is the only process with an additional variable that may result in discoloration due to heat.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 when using the bd insyte¿ autoguard¿ bc shielded iv catheter there was foreign matter on the needle cover.The following information was provided by the initial reporter.The customer stated: "dirt was found on the needle cover.".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12755280
• MDR Text Key: 285224745
• Report Number: 1710034-2021-00952
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381023
• Device Lot Number: 0337822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1