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

Catalog Number 381034

Device Problem Contamination (1120)

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

Event Date 02/01/2023

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 dirt was found near the bd insyte¿ autoguard¿ bc shielded iv catheter needle tip.The following information was provided by the initial reporter, translated from japanese: "this is a report about foreign matter (dirt) on the needle tip of iagbc.According to the customer's report, when an unused product was checked before use, dirt was found near the needle tip.".

Event Description

It was reported that dirt was found near the bd insyte¿ autoguard¿ bc shielded iv catheter needle tip.The following information was provided by the initial reporter, translated from japanese: "this is a report about foreign matter (dirt) on the needle tip of iagbc.According to the customer's report, when an unused product was checked before use, dirt was found near the needle tip.".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one sealed 20g x 1.16in.Insyte autoguard bc pro unit from lot number 2136394.Additionally, seven photos were provided for investigation which displayed similarities to that of the returned unit.A gross visual inspection of the returned unit found that three black specks of foreign material (fm) were embedded in the needle cover.No foreign matter was found in the fluid path.The specks were measured using a tappi dirt estimation chart.The unit had particles that when combined measured to be unacceptable.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.The material was determined to be burnt particulate resin (non-foreign).The black specks were most likely created as part of the molding process.Burnt imbedded 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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16441425
• MDR Text Key: 310245833
• Report Number: 1710034-2023-00147
• 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: 03/20/2023

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 Catalogue Number: 381034
• Device Lot Number: 2136394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/26/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1