MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-24703-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when changing the dressing in the icu, part of the catheter was removed with the opsite. As a result, new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

(b)(4). Device evaluation: the report that the catheter migrated could not be confirmed. Returned was a 3-l catheter marked 7fr x 30cm on the hub and a catheter box clamp. The clamp was fastened just below the 17cm mark on the catheter. The catheter and the box clamp appeared typical. The clamp was removed from the catheter. The od of the catheter body extrusion measured 0. 096". This met specification per catheter graphic. The id of the clamp could not be measured since the clamp material is pliable and it had been used on a patient. The clamp and the clamp fastener were reassembled. The largest pin gauge that would pass through the clamp assembly without resistance was 0. 077". This indicates that the clamp would securely hold a catheter that has an od of 0. 096". The clamp and clamp fastener were assembled onto the catheter body just below the 17cm mark. The catheter was tugged from either side and remained secure in the clamp. It was not reported by the customer whether or not the juncture hub was used as the primary suture site per the instruction booklet. The device history records, based on sales history, were reviewed with other remarks: no evidence to suggest a manufacturing related issue. No problem was found on the returned sample. No further action will be taken at this time.

Manufacturer Narrative

(b)(4). A re-investigation was performed on the sample. A visual exam was performed and it was observed that a clamp was fastened just below the 17cm mark on the catheter. Inspection of the catheter revealed a hole in the body near the 24cm marking. Microscopic examination showed that the edges of the hole were sharp and the exposed wall of the extrusion was generally smooth with light striations. The surface of the catheter body exhibited residue from use, but the walls of the hole were clean with no residue. This indicates that the hole was exposed at the end of use, otherwise the walls of the hole would have exhibited residue from use. The outer diameter of the catheter body was measured and found to be within specification. Simulations were performed in an attempt to reproduce the defect. Two different types of adhesive tape from the lab were applied to the surface of the returned catheter on either side of the hole and then removed. No catheter material was removed. The test was repeated and no catheter material was removed. A scalpel was then used to cut the body of a catheter from lab inventory. This resulted in a hole that appeared similar to complaint sample. Other remarks: the scalpel was used to cut the catheter body again, but not all the way through, leaving a small amount of material attached to the surface. Two types of adhesive tape were applied over the cut and then removed in an attempt to pull off the flap of catheter material, but the cut material would not separate from the catheter body. A pair of tweezers was used to remove the cut material. The report that a hole was observed in the catheter body while changing the dressing was confirmed through examination of the returned sample. A hole was found in the catheter body near the 24cm mark. Simulations showed that adhesive tape would not remove material from the catheter body; however, cutting a lab catheter with a scalpel produced a hole that was similar in appearance to the complaint sample. Based on the appearance of the hole and the report that it was observed during a dressing change, it was determined that operational context caused or contributed to this event.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• 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: 5701790
• MDR Text Key: 46668355
• Report Number: 3006425876-2016-00165
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CS-24703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/08/2017
• 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