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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN000099
Device Problems No Device Output (1435); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after insertion of the catheter the connectors on the devices were not working.As a result, device was removed and replaced with a different brand.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "connectors on the devices were not working" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that after insertion of the catheter the connectors on the devices were not working.As a result, device was removed and replaced with a different brand.There was no report of patient complications, serious injury or death.
 
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Brand Name
CATH PKGD: THERMISTOR 7 110CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9836821
MDR Text Key183739722
Report Number3010532612-2020-00074
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00801902004567
UDI-Public00801902004567
Combination Product (y/n)N
PMA/PMN Number
K823433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Model NumberIPN000099
Device Catalogue NumberAI-07167
Device Lot Number16F19G0006
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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