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

Catalog Number 401622

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

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

Event Date 08/22/2018

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 that the connection on the bd durasafe plus¿ epidural lock cse needle set was not tight enough, and could not reflect the difference in the spinal canal.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

A device history review was conducted for lot number 7352025 our records show it was manufactured february 2018; it was determined that this is the only instance of a syringe needle connectivity issue occurring in this lot.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 of packaged goods.A photo was submitted by your facility to aid identifying the root cause for this event.The photo showed excessive adhesive swelling out of the connection point of the device; unfortunately a physical sample could not be obtained for evaluation and testing.Without the ability to evaluate the affected unit, our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the connection on the bd durasafe plus epidural lock cse needle set was not tight enough, and could not reflect the difference in the spinal canal.There was no report of exposure, serious injury or medical intervention.

• 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: 7869510
• MDR Text Key: 120387239
• Report Number: 3006948883-2018-00176
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 401622
• Device Lot Number: 7352025
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other