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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 Material Deformation (2976)
Patient Problem No Information (3190)
Event Date 12/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint was received via (b)(6) survey.It was reported that the knotting of the catheter occurred during use on a patient.
 
Event Description
The complaint was received via teleflex berman and wedge catheter survey.It was reported that the knotting of the catheter occurred during use on a patient.
 
Manufacturer Narrative
(b)(4).No part has returned to teleflex chelmsford for investigation.The complaint was received from a customer survey.The reported complaint that the "knotting of the catheter occurred" is not able to be confirmed.If the product is returned at a later date, a full in vestigation of the sample will be completed.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 not 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 Key11130731
MDR Text Key227020614
Report Number3010532612-2021-00004
Device Sequence Number1
Product Code DYG
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
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? Yes
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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