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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-24703-E
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: it was reported that the doctor noted blood and liquid around the film.Then changing the film and the leakage occurred again.There was leakage on the film, but the area around the puncture site was dried.It was found there was a 2mm hole at the 21cm of catheter according to the leakage on the film.The infusion of the medicine was stopped , and the catheter was clamped.The catheter was removed.
 
Event Description
The customer reports: it was reported that the doctor noted blood and liquid around the film.Then changing the film and the leakage occurred again.There was leakage on the film, but the area around the puncture site was dried.It was found there was a 2mm hole at the 21cm of catheter according to the leakage on the film.The infusion of the medicine was stopped , and the catheter was clamped.The catheter was removed.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9273226
MDR Text Key167014428
Report Number3006425876-2019-00884
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/11/2020
Device Catalogue NumberCS-24703-E
Device Lot Number71F18K0515
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/24/2019
Initial Date FDA Received11/04/2019
Supplement Dates Manufacturer Received12/10/2019
Supplement Dates FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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