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

Catalog Number 382933

Device Problem Contamination (1120)

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

Event Date 03/26/2022

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 that black foreign matter was found in the cap of the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology.The following information was provided by the initial reporter, translated from french: "black dots on the cap of the device.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 05-may-2022.H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one sealed 20g x 1.00in.Insyte autoguard bc pro winged unit from lot number 1312554.Additionally, two photos were received for investigation.A gross visual inspection found that black specks of foreign material were present throughout the needle cover.Microscopic inspection confirmed that all the black specks were embedded in the needle cover.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the molding process.Burnt embedded resin specks result from material build up in the barrel/screw.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 black foreign matter was found in the cap of the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology.The following information was provided by the initial reporter, translated from french: "black dots on the cap of the device.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14289041
• MDR Text Key: 291396186
• Report Number: 1710034-2022-00227
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382933
• Device Lot Number: 1312554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• 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