MAUDE Adverse Event Report: BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET; ANESTHESIA CONDUCTION KIT

Catalog Number 401622

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd durasafe plus¿ epidural lock cse needle set was shorter than it was supposed to be.This was noticed prior to use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the epidural needle was shorter than normal".

Event Description

It was reported that the bd durasafe plus¿ epidural lock cse needle set was shorter than it was supposed to be.This was noticed prior to use.The following information was provided by the initial reporter, translated from chinese to english: "the epidural needle was shorter than normal".

Manufacturer Narrative

H.6.Investigation summary: a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally photographs of the non-conformance were obtained from the facility.Visual analysis of markings found on the surface of the devices found that the two units do not share the same item number designation.This suggests that the issue is not related to a mixing of product lines, most likely occurring as a result of poor line clearance when changing product lines.Bd will continue to track and trend for this issue.H3 other text : see h.10.

• Brand Name: BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10033248
• MDR Text Key: 194649262
• Report Number: 3006948883-2020-00170
• Device Sequence Number: 1
• Product Code: CAZ
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other