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U.S. Department of Health and Human Services

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

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BD CARIBE LTD. BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET EPIDURAL KIT Back to Search Results
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.
 
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Brand NameBD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
Type of DeviceEPIDURAL 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 Key7310298
MDR Text Key101404074
Report Number2618282-2018-00006
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier30382904002863
UDI-Public30382904002863
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K932249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
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 Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue Number400286
Device Lot Number6159717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2018 Patient Sequence Number: 1
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