MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381812

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Perforation (2001)

Event Date 07/19/2021

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 the puncture damaged the bd insyte¿ autoguard¿ shielded iv catheter tip, causing the needle to pierce through it.The following information was provided by the initial reporter, translated from (b)(6) to english: "at the time of using the peripheral iv catheter, the puncture damaged the tip, injuring the baby, and caused multipuncture." "venous access damaged, in the left arm, brachial area, it was necessary to puncture again for which the other arm was chosen.It was not necessary medical intervention or use of pharmacological treatment.".

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, 0167294, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed that the needle had pierced through the catheter tubing.Based off the provided photos the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for investigation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h10.

Event Description

It was reported that the puncture damaged the bd insyte¿ autoguard¿ shielded iv catheter tip, causing the needle to pierce through it.The following information was provided by the initial reporter, translated from spanish to english: "at the time of using the peripheral iv catheter, the puncture damaged the tip, injuring the baby, and caused multipuncture"."venous access damaged, in the left arm, brachial area, it was necessary to puncture again for which the other arm was chosen.It was not necessary medical intervention or use of pharmacological treatment".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12357343
• MDR Text Key: 267821166
• Report Number: 1710034-2021-00741
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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 Expiration Date: 05/31/2023
• Device Model Number: 381812
• Device Catalogue Number: 381812
• Device Lot Number: 0167294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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