MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET; EPIDURAL KIT

Catalog Number 401622

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/01/2018

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 by the nurse that the stopper of the bd durasafe plus¿ epidural lock cse needle set seperated fom the plunger rod before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.Investigators were unable to observe the reported failure mode in the sample provided, the plungers in both returned samples were joined to the body of the device.The batch record also was reviewed for insight into potential complications during the manufacturing process, but no related abnormalities were found.Without the ability to observe the reported failure mode the root cause could not be determined.Bd will continue to track and trend for this issue.

Event Description

It was reported by the nurse that the stopper of the bd durasafe plus¿ epidural lock cse needle set seperated fom the plunger rod before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted field: device returned to manufacture: yes.The following field was filled out incorrectly.Method codes: 10 replaces 4114.

Event Description

It was reported by the nurse that the stopper of the bd durasafe plus¿ epidural lock cse needle set seperated fom the plunger rod before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 7634492
• MDR Text Key: 112448912
• Report Number: 3006948883-2018-00101
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 401622
• Device Lot Number: 7261012
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other