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

Catalog Number 382933

Device Problem Packaging Problem (3007)

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

Event Date 11/17/2022

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 by the customer that 5 of the bd insyte¿ autoguard¿ bc shielded iv catheters was not sealed and had black paper at the end.The following information was provided by the initial reporter: while counting out material on our kitting line the operators found 5 catheters with the blister packs not sealed.The blister pack had black paper at the end of the pack which we suspect may prevented the correct sealing of the blister (see attached photo).

Manufacturer Narrative

H6: investigation summary a physical sample was not available for investigation but bd was provided with two photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 2129667, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed five 20 gauge insyte autoguard bc pro winged devices with black tape on the underside of the packaging.The five units appeared to be opened where the tape was present.Therefore, based off the provided photos the engineer was able to verify the reported defect.H3 other text : see h10.

Event Description

It was reported by the customer that 5 of the bd insyte¿ autoguard¿ bc shielded iv catheters was not sealed and had black paper at the end.The following information was provided by the initial reporter: while counting out material on our kitting line the operators found 5 catheters with the blister packs not sealed.The blister pack had black paper at the end of the pack which we suspect may prevented the correct sealing of the blister (see attached photo).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS
• 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: 15955937
• MDR Text Key: 308075342
• Report Number: 1710034-2022-00783
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382933
• Device Lot Number: 2129667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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