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

Catalog Number 382544

Device Problems Leak/Splash (1354); Material Perforation (2205)

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

Event Date 07/08/2023

Event Type  malfunction  

Manufacturer Narrative

E.4.: the initial reporter also notified the fda on 21jul2023.Medwatch report # mw5120019 h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter a hole in the catheter caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: went to place an 18 gauge angiocatheter in the patient's right ac, the angio had a hole in it causing it to leak.Catheter was removed intact with hole present.Patient had iv site moved to left arm.

Event Description

It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter a hole in the catheter caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: went to place an 18 gauge angiocatheter in the patient's right ac, the angio had a hole in it causing it to leak.Catheter was removed intact with hole present.Patient had iv site moved to left arm.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17638400
• MDR Text Key: 322422942
• Report Number: 1710034-2023-00959
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: (01)30382903825449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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: 382544
• Device Lot Number: 3083902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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