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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-12853-E
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Pneumothorax (2012)
Event Date 12/27/2018
Event Type  Death  
Manufacturer Narrative

(b)(4). Potential lot numbers: 71f18k0103, 71f18j2296, 71f18h1770. Pneumothorax classified as iatrogen pneumothorax. To date, the user facility does not indicate if the alleged issue with the device caused or contributed to the patient's death. Investigation: the customer report of incorrect needle dimensions could not be confirmed from evaluation of the returned sample. The customer returned a needle that dimensional and visual examination revealed was the 20ga needle from the catheter-over-needle assembly. No defects or anomalies were observed with the needle and it met all relevant dimensional requirements. An 18ga introducer needle is also supplied in this set which was not returned by the customer. The ifu supplied with this product details the differences in technique when using the catheter-over-needle and the 18ga introducer needle. Other remarks: a device history record was performed based on sales history review and no relevant issues were identified. Based on the returned needle, no problem was found with the sample. Teleflex will continue to monitor, and trend reports of this nature. Corrective action is not required as no problem was found with the sample returned by the customer.

 
Event Description

The customer reports the needle is thinner and longer than usual. Clinical consequence: a major pneumothorax.

 
Manufacturer Narrative

(b)(4). Additional information was received from the customer. The customer reports that the needle contributed to the pneumothorax that the patient sustained and that the device caused or contributed to the patient death. They also reported "the needle used for the puncture of the vein was not in the kit. The only needle in the kit was the long and thin needle without the catheter. It's this needle that caused the pneumothorax". Although the customer reports that the device caused or contributed to the patient death, the complaint of incorrect needle dimensions could not be confirmed from evaluation of the returned sample. The customer returned a needle that dimensional and visual examination revealed was the 20ga needle from the catheter-over-needle assembly. No defects or anomalies were observed with the needle and it met all relevant dimensional requirements. An 18ga introducer needle is also supplied in this set which was not returned by the customer. The ifu supplied with this product details the differences in technique when using the catheter-over-needle and the 18ga introducer needle. Other remarks:.

 
Event Description

The customer reports the needle is thinner and longer than usual. Clinical consequence: a major pneumothorax.

 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 16CM
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 Key8290194
MDR Text Key134510596
Report Number3006425876-2019-00047
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 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCS-12853-E
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/24/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? No
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: 01/30/2019 Patient Sequence Number: 1
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