MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNSPECIFIED BD WEISS EPIDURAL NEEDLE; ANESTHESIA SPINAL NEEDLE

Catalog Number 408356

Device Problems Crack (1135); Leak/Splash (1354); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

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 during use an unspecified bd¿ weiss epidural needle was found cracked/ leaking as ¿there is a crack in the hub which in any opportunity when connecting the syringe occurring loss of resistance and anesthesia can occur during the anesthetic procedure.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Five samples were received for investigation.The five samples were visually inspected for damage and some marks on the hub of the needle were observed, but they did not have any cracks or holes on them.The units were then leak tested and no leakage was observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7332996.We were unable to determine a root cause for this occurrence.

• Brand Name: UNSPECIFIED BD WEISS EPIDURAL NEEDLE
• Type of Device: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7359270
• MDR Text Key: 103314182
• Report Number: 9610048-2018-00033
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 408356
• Device Lot Number: 7332996
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other