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

Catalog Number 401622

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2019

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 that 2 cases of bd durasafe plus¿ epidural lock cse needle sets had "black spots" found in them before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "according to customer feedback, 2 cases have black spots".

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8232449.Our records show that this is the only instance of this issue occurring in this production batch.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, they did not display the failure mode clearly enough to identify the root cause.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.

Event Description

It was reported that 2 cases of bd durasafe plus¿ epidural lock cse needle sets had "black spots" found in them before use.The following information was provided by the initial reporter, translated from chinese to english: "according to customer feedback, 2 cases have black spots.".

• Brand Name: BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9538555
• MDR Text Key: 181440416
• Report Number: 3006948883-2019-01153
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 401622
• Device Lot Number: 8232449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other