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

Catalog Number 401622

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8103004, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-13.Medical device lot #: 8103006, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-13.Medical device lot #: 8138084, medical device expiration date: 2023-05-31, device manufacture date: 2018-05-18.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd durasafe plus¿ epidural lock cse needle set was found to have the green part of the connector cracked.There are seven connector with cracks.

Event Description

It was reported that during use of the bd durasafe plus¿ epidural lock cse needle set was found to have the green part of the connector cracked.There are seven connector with cracks.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8103004, 8103006, and 8138084.Our records show that this is the only instance of this issue occurring in any of these production batchs.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, clearly displaying the reported failue mode.Unfortunately, the root cause for this complaint could not be determined without the return of the affected device.

• 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: 8287179
• MDR Text Key: 134460632
• Report Number: 3006948883-2019-00111
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904016227
• UDI-Public: 382904016227
• 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
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401622
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other