MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM; CATHETER PERCUTANEOUS

Catalog Number DE-15853-MKHS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is not intended for sale in the us.A similar device/component is sold in the us.

Event Description

The customer alleges that the box clamp was not tight enough and the catheter moved/dislocated.A new catheter was used successfully.

Manufacturer Narrative

(b)(4).One 3-lumen cvc catheter was returned for evaluation.The sample had evidence of use, the catheter box clamp was attached to the catheter body and suture thread was attached to one of the box clamp wings.Visual examination with the naked eye did not reveal any defects or anomalies.The catheter box clamp appeared used but undamaged.Microscopic examination of the juncture hub suture wings of the catheter (primary suture site) did not reveal any obvious signs of use/wear.Evidence of use was observed on the catheter box clamp, although no damage was observed.Residual adhesive was observed on the catheter body between the juncture hub and the box clamp.The catheter body outer diameter was measured and found to be within specification.The catheter clamp fastener inner diameter and the catheter clamp inner diameter were measured and were also with specification.The clamp and the clamp fastener were reassembled.The largest pin gauge that would pass through the clamp assembly without resistance was 0.098".This indicates that the clamp would securely hold a catheter that has an outer diameter of 0.114" (2.895mm).The box clamp was placed on the catheter and the catheter body was then tugged on either side.The catheter remained in place.A device history record (dhr) review was performed on the catheter and box clamp components and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit states to use the triangular juncture hub with side wings as primary suture site.The catheter clamp and fastener should be used as a secondary suture site if necessary.The customer did not state whether or not the primary suture site was used.The ifu also states to secure catheter clamp and fastener as a unit to patient by using either catheter stabilization device, stapling or suturing.Both catheter clamp and fastener need to be secured to reduce risk of catheter migration.It was reported that the cvc catheter migrated out of the patient while in use.The customer did not report whether the primary suture site (juncture hub) was used; however, no obvious signs of use were observed on the juncture hub suture wings during investigation.The reported issue could not be confirmed through functional or dimensional testing of the returned sample.The catheter remained secure in the catheter clamp when it was tugged and the components met all relevant dimensional specifications.A dhr record review did not reveal any manufacturing related issues.No problem was found on the sample.

Event Description

The customer alleges that the box clamp was not tight enough and the catheter moved/dislocated.A new catheter was used successfully.

• Brand Name: ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM
• Type of Device: CATHETER 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 Key: 6847968
• MDR Text Key: 85115365
• Report Number: 3006425876-2017-00386
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• 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: 08/29/2017

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 Catalogue Number: DE-15853-MKHS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 10/26/2017
• 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
• Patient Sequence Number: 1