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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 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
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.
 
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.
 
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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
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 Key7130605
MDR Text Key255275563
Report Number3006948883-2017-00181
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2018
Device Catalogue Number401622
Device Lot Number3141316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2013
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: 12/19/2017 Patient Sequence Number: 1
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