MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD WHITACRE NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 408394

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

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

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.(b)(4).

Event Description

It was reported that the bd whitacre¿ needle was found damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the package, it was verified that the needle was bent; damaged.".

Manufacturer Narrative

H.6.Investigation summary: 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.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.

Event Description

It was reported that the bd whitacre¿ needle was found damaged before use.The following information was provided by the initial reporter, translated from portuguese to english: "when opening the package, it was verified that the needle was bent; damaged.".

• Brand Name: BD WHITACRE NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10588565
• MDR Text Key: 209171989
• Report Number: 9610048-2020-00133
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 408394
• Device Lot Number: 8010903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other