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

Catalog Number 382523

Device Problem Break (1069)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd insyte¿ autoguard¿ bc shielded iv catheter broke.The following information was provided by the initial reporter: "after entering the vein and seeing a flash, when we went to advance the catheter, it would bend at the insertion site breaking the catheter.This happened multiple times.I have been using these for 2 years and this has never happened.".

Manufacturer Narrative

H6: investigation summary: bd received five sealed 22 gauge insyte autoguard blood control units from lot 2305381 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical damage or deformities.There were no visible bends or breaks found to the catheters.Next, the units were tested for functionality.The engineer attempted to puncture a latex tub to simulate venipuncture and catheter advancement.No bending or breaking was observed during testing and the units were found to be functioning as intended.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during investigation a definitive root cause could not be determined.

Event Description

It was reported that 3 bd insyte¿ autoguard¿ bc shielded iv catheter broke.The following information was provided by the initial reporter: "after entering the vein and seeing a flash, when we went to advance the catheter, it would bend at the insertion site breaking the catheter.This happened multiple times.I have been using these for 2 years and this has never happened.".

• 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: 16443342
• MDR Text Key: 310250507
• Report Number: 1710034-2023-00148
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: (01)00382903825233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382523
• Device Lot Number: 2305381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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