MAUDE Adverse Event Report: BD PERISAFE¿ 18GA 3-1/2IN; ANESTHESIA CONDUCTION KIT

Model Number 400273

Device Problem Leak/Splash (1354)

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

Event Date 04/17/2021

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 while using bd perisafe¿ 18ga 3-1/2in there was an issue with needle.The following information was provided by the initial reporter: while using issue with the needle.

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that while using bd perisafe¿ 18ga 3-1/2in there was an issue with needle.The following information was provided by the initial reporter: while using issue with the needle.

• Brand Name: BD PERISAFE¿ 18GA 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11829637
• MDR Text Key: 264510090
• Report Number: 2618282-2021-00027
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0063313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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