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

Catalog Number 401622

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/21/2017

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 before use of the bd durasafe plus¿ epidural lock cse needle set the plastic package was found open when picked up from case.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: bd received representative samples and two photographs of the actual defective sample from the customer for evaluation.The failure mode was observed in the photographs provided, but not in the representative samples.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.Because the photograph was not clear enough to conduct and inspection on the actual defective sample and the actual sample was not available for review the failure mode could not be duplicated by the investigator.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for package integrity was not observed as all samples met specifications.Without the ability to investigate the defect reported the root cause could not be determined.Conclusion: unable to determine a root cause.The returned representative samples were checked ok, no open seal found.The actual defect samples were not returned.It was not sure whether it was related to sz plant.

• 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
• 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: 7130605
• MDR Text Key: 95813658
• Report Number: 3006948883-2017-00181
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 401622
• Device Lot Number: 3141316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2013
• 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