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

Catalog Number 401622

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: a sample was not received for the purpose of our investigation.Three issues were noted in the original complaint.Photos were provided only for the failure mode related to the towel.The photo clearly shows the towel lacked a hole, our investigators determined that this is a defect with the material and should have been identified.Neither samples or photographs were provided for the purpose of our investigation in the leakage or coloration complaints.As a result the root cause for neither of these could be determined at this time.Bd will continue to track and trend for this issue.Production process survey: the batch number of the customer¿s feedback was investigated, product number : 401622, lot number: 7324049.Production date: december 2017, quantity 1.4k.Check the batch records of the batch and there is no abnormality in the production process.

Event Description

It was reported that the disposable towel in the bd durasafe plus¿ epidural lock cse needle set, did not have a hole as intended for a proper sterile field.It was also reported that there was cerebrospinal fluid leakage between the puncture needle and the syringe while taking the sample, this resulted in inaccurate administration, and possible headache complications after surgery.There was no report of exposure, injury or medical intervention.

• 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
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7446757
• MDR Text Key: 106858447
• Report Number: 3006948883-2018-00047
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 401622
• Device Lot Number: 7324049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2017
• 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