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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS Back to Search Results
Model Number IPN030899
Device Problems Complete Blockage (1094); Material Twisted/Bent (2981)
Patient Problem Death (1802)
Event Date 06/04/2020
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that: involving a covid-19 female patient that was in resuscitation department prior to the incident. During use, the distal catheter extension line twisted in/fold on itself. The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again. No medical intervention was necessary. The patient is deceased , but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid-19 few hours later.

 
Manufacturer Narrative

(b)(4). The customer returned one 2-lumen cvc for evaluation. The catheter body contained slight signs of use in the form of biological material. Visual examination of the catheter did not reveal any defects or anomalies. The extension lines did not contain creases or bends. The total length of the catheter body measured to be 215 mm which is within specifications of 207-227 mm per product drawing. The catheter was flushed using a water-filled lab inventory syringe. No leaks or blockages were detected. A lab inventory guide wire was able to pass through the returned catheter with minimal resistance. A device history record review was performed on the lot number reported (71f19k2279) with no relevant findings. The instructions-for-use provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow. Secure only at indicated stabilization locations. " the customer report of blocked/kinked extension lines could not be confirmed by complaint investigation of the returned sample. The sample passed all relevant visual, dimensional, and functional testing. A device history record review was performed with no relevant findings. No problem was found with the returned sample. Teleflex will continue to monitor and trend for complaints of this nature.

 
Event Description

It was reported that: involving a covid - 19 female patient that was in resuscitation department prior to the incident. During use, the distal catheter extension line twisted in/fold on itself. The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again. No medical intervention was necessary. The patient is deceased, but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid - 19 few hours later. Several attempts were made to gather additional information from the customer; however, the customer has not responded.

 
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Brand NameARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key10158236
MDR Text Key195264827
Report Number3006425876-2020-00521
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030899
Device Catalogue NumberCV-16702
Device LOT Number71F19K2279
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/16/2020 Patient Sequence Number: 1
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