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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. ADAPTOR TUOHY-BORST; INTERVENTIONAL IMAGING|ACCESSORIES
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SMITHS MEDICAL ASD,INC. ADAPTOR TUOHY-BORST; INTERVENTIONAL IMAGING|ACCESSORIES Back to Search Results
Model Number ADAPTOR TUOHY-BORST
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Information received a smiths medical adaptor tuohy-borst reported duing use the adapter put on endoscope had a fluid leak.The cap was manipulated with no resolution.Photos were provided of malfunction.No patient adverse events were reported.
 
Manufacturer Narrative
Pictures of the adaptor tuohy-borst adaptor were received for analysis.It was observed through the pictures that the catheter seal ring was open and not closed.Trials were executed in order to replicate defect: reported kept rotating the cap to shut the packing (o-ring) but it became non-functional.It was observed when the knob its completely closed the o-ring closed (picture 3) when the knob is open the seal ring is open too (picture 4), like the pictures provided.Through the pictures provided it was not possible to analyze why the seal-ring became functional.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.
 
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Brand Name
ADAPTOR TUOHY-BORST
Type of Device
INTERVENTIONAL IMAGING|ACCESSORIES
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key10031096
MDR Text Key190304127
Report Number3012307300-2020-03739
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberADAPTOR TUOHY-BORST
Device Catalogue NumberB1220
Device Lot Number3815699
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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