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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL
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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Inflation Problem (1310)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Complaint was received via the berman & wedge survey negative responses.It was reported that the balloon does not open symmetrically.
 
Event Description
Complaint was received via the berman & wedge survey negative responses.It was reported that the balloon does not open symmetrically.
 
Manufacturer Narrative
Qn# (b)(4).The complaint was received from a customer survey and no product was returned for investigation.The reported complaint that the "balloon does not open symmetrically" is not able to be confirmed.The root cause of the complaint is undetermined.The complaint was received from a customer survey and the specific material/lot number was not reported.A lot number history for this account was unable to be retrieved.If lot number information is available at a later date, the complaint will be updated accordingly.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
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Brand Name
CARDIAC UNKNOWN DUMMY MATERIAL
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10959438
MDR Text Key220656634
Report Number3010532612-2020-00369
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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