MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CV-12712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the cvc was placed into the right subclavia vein on (b)(6) 2017.On (b)(6) 2017 an extravasation of the right breast/shoulder was noted and fluid/medication dropped out at the puncture site.During removal of the cvc it was noted that the cvc was migrated (out of the patient).Therapy delayed/interrupted.A new catheter was placed without issue.No patient injury or harm.

Manufacturer Narrative

(b)(4).One 2-lumen cvc catheter was returned for evaluation.The sample had evidence of use, the catheter box clamp was attached to the catheter body and stopcock extensions were attached to each of the catheter extension lines.Visual examination with the naked eye did not reveal any defects or anomalies.Microscopic examination of the juncture hub suture wings of the catheter revealed they did not appear to have damage/wear.Evidence of use was observed on the catheter box clamp insert as the suture holes were laterally pinched, indicating sutures had been applied.The catheter body outer diameter (od) was measured and was found to be within specification.The catheter clamp fastener diameter and the catheter clamp inner diameter (id) were also measured and were within specification.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 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 no relevant manufacturing issues were identified.The instruc tions-for-use (ifu) provided with this kit states that the catheter clamp and fastener can be used as a secondary securement site is needed in addition to the primary securement site, the catheter juncture hub.The ifu also states that indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position and for secure luer-lock connection.It was reported that the cvc catheter migrated out of the patient while in use.Customer reported that 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 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 dimensional specifications.A dhr review did not reveal any manufacturing related issues.No problem was found on the sample.

Event Description

The customer reports that the cvc was placed into the right subclavia vein on (b)(6) 2017.On (b)(6) 2017 an extravasation of the right breast/shoulder was noted and fluid/medication dropped out at the puncture site.During removal of the cvc it was noted that the cvc was migrated (out of the patient).Therapy delayed/interrupted.A new catheter was placed without issue.No patient injury or harm.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
• 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: 6764319
• MDR Text Key: 81730356
• Report Number: 3006425876-2017-00248
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

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: CV-12712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 09/15/2017
• 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