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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 20 CM; CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-15703
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: during the passage of the catheter, no blood return is obtained through the blue route, the permeability is removed and verified with saline solution, but it does not leak or return.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Event Description
The customer reports: during the passage of the catheter, no blood return is obtained through the blue route, the permeability is removed and verified with saline solution, but it does not leak or return.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10029775
MDR Text Key190054544
Report Number3006425876-2020-00399
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 04/21/2020
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 No Information
Device Expiration Date07/31/2023
Device Catalogue NumberCV-15703
Device Lot Number14F19G0368
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/21/2020
Initial Date FDA Received05/06/2020
Supplement Dates Manufacturer Received06/05/2020
Supplement Dates FDA Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.; UNKNOWN.
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