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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 20CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-15853
Device Problems Break (1069); Migration or Expulsion of Device (1395)
Patient Problems High Blood Pressure/ Hypertension (1908); No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports that the little wings in the plastic sheared by the suture thread. The suture thread stayed on the skin of the patient. The catheter was found detached in the bed of the patient. The catheter was removed and replaced. The customer reports high blood pressure and no bleeding.

 
Manufacturer Narrative

(b)(4). The customer returned one catheter for investigation. Visual examination of the returned catheter revealed that both wings of the suture site on the juncture hub were severed. Microscopic examination of the point of separation revealed that the material is uneven and jagged. No pieces appear to be missing. No additional defects or anomalies were observed. The lot number was not reported by the customer; therefore, sales history records were reviewed for the most recent lot sold to the customer prior to the event. A device history record (dhr) review was performed on that lot number and there were no relevant findings. The instructions-for-use (ifu) that are packaged with this product suggest using the catheter clamp and fastener as secondary securement sites to mitigate the risk of catheter migration. The reported complaint of the migration of the catheter was confirmed through visual examination of the returned sample. Both suture wings were found to be torn. Visual examination of the point of separation revealed that the material appeared jagged and uneven as if the material was torn. A dhr review was performed based on sales history with no evidence to suggest a manufacturing related cause. Based upon the complaint report, which states, "the little wings in plastic were sheared by the suture thread," the torn suture wings caused the catheter to migrate. Based on that description and the type of damage observed, it was determined that operational context caused or contributed to this event.

 
Event Description

The customer reports that the little wings in the plastic sheared by the suture thread. The suture thread stayed on the skin of the patient. The catheter was found detached in the bed of the patient. The catheter was removed and replaced. The customer reports high blood pressure and no bleeding.

 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 20CM
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 Key6947513
MDR Text Key89727544
Report Number3006425876-2017-00446
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCS-15853
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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