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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET EPIDURAL KIT Back to Search Results
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.
 
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Brand NameBD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET
Type of DeviceEPIDURAL KIT
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key7869510
MDR Text Key120387239
Report Number3006948883-2018-00176
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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 Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number401622
Device Lot Number7352025
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/12/2018 Patient Sequence Number: 1
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