MAUDE Adverse Event Report: BD CARIBE LTD. BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET; EPIDURAL KIT

Catalog Number 400286

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during retraction of a bd durasafe plus¿ epidural lock cse needle set, the distal part of the catheter remained in the tissues of the patient.It was not possible to verify the exact positioning of the part and no further consequences were reported because they did not identify any part of the catheter in the patient's body.

Manufacturer Narrative

Investigation results: an investigation has been completed without a picture or a sample returned for examination.Unfortunately we are not able to verify the reported issue as a result of no pictures or samples.In addition, an accurate root cause was not able to be determined.This is the 1st related complaint reported with the defect/condition of tear of the catheter during the partial retraction with lot #6159717 regarding item #400286.The manufacturing records were reviewed for the incident lot and no discrepancies or non-conformances were reported that could have contributed to the reported condition.The results of the pull test inspection were within the specification requirements of 8 pounds minimum for cannula as per product specification (b)(4).Based on the above, no further corrective action is required at this time.

• Brand Name: BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7310298
• MDR Text Key: 101404074
• Report Number: 2618282-2018-00006
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002863
• UDI-Public: 30382904002863
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K932249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 400286
• Device Lot Number: 6159717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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): Required Intervention
• Patient Age: 22 YR