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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event. Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event. Examination of the product involved may provide clarification as to the cause for the reported failure. Investigation conclusion: no sample, no lot. Root cause description: no sample, no lot. Rationale: no sample, no lot.
 
Event Description
It was reported that unspecified bd¿ catheter package was damaged. No serious injury or medical intervention was reported. The following information was provided by the initial reporter: ¿it was found package damaged when opening the package. Rep feedback customer wasn't sure package damaged during transfusion or person' used then put back again. Md registration certificate# (b)(6).
 
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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 Key8465049
MDR Text Key141047412
Report Number3006948883-2019-00222
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received03/19/2019
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: 03/29/2019 Patient Sequence Number: 1
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