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

Model Number	400273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11829637
• Report Number: 2618282-2021-00027
• Device Sequence Number: 4308884
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Other
• Device Expiration Date: 02/28/2025
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0063313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1