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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) UNSPECIFIED BD¿ CATHETER

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BD (SUZHOU) UNSPECIFIED BD¿ CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Slipped (1584)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/04/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: unfortunately, a valid lot number and physical sample could not be obtained for the purpose of aiding in our investigation. As a result, bd engineers were unable to identify a root cause or trending data regarding this event. Bd will continue to track and trend for this issue investigation conclusion: lot number could not be validated using sap.
 
Event Description
It was reported that unspecified bd¿ catheter needle slipped out during usage and caused a needle stick injury. The following information was provided by the initial reporter: the needle slipped out during the usage, which caused stick injury. The injury was treated immediately by using mupirocin ointment. The patient's injury recovered.
 
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Brand NameUNSPECIFIED BD¿ CATHETER
Type of DeviceCATHETER
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
8015652341
MDR Report Key8671868
MDR Text Key147096514
Report Number3006948883-2019-00436
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot Number8141415
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 Received05/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/05/2019 Patient Sequence Number: 1
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