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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL ADAPTOR TUOHY-BORST; ACCESSORIES, CATHETER
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NULL ADAPTOR TUOHY-BORST; ACCESSORIES, CATHETER Back to Search Results
Catalog Number B1220
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during use of the device, there was leakage from the adaptor.Nothing passed through the adaptor when leakage occurred.No patient injury was reported.
 
Manufacturer Narrative
Manufacturing site address is unknown.: udi information is unknown.Premarket (510k) number is unknown.No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
 
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Brand Name
ADAPTOR TUOHY-BORST
Type of Device
ACCESSORIES, CATHETER
Manufacturer (Section G)
NULL
MDR Report Key15326643
MDR Text Key305346486
Report Number3012307300-2022-16918
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberB1220
Device Lot Number3983885
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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