MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 12 FR X 25 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CS-16123-F

Device Problem Reflux within Device (1522)

Patient Problem Blood Loss (2597)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

It was reported that "when users plugged the dialysis they noticed a blood reflux on the 2 lumens: medial and proximal despite the fact that the tubes had been clamped." there was a loss of blood of about 20 to 30 ml but no other clinical consequences.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned a catheter with both extension line clamps.The catheter appeared typical but used.The extension line clamps were closed on the proximal and medial extension lines.Each line was leak tested with a 10 ml syringe with each clamp closed separately.No water exited the catheter through any of the lines.Another leak test was performed utilizing the leak tester.Water was able to flow through the catheter without the clamps, and the clamps each successfully occlude each line.A review of manufacturing records did not yield any relevant findings.The investigation found no evidence to indicate a manufacturing related cause.There was no problem found with the returned sample.No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 12 FR X 25 CM
• Type of Device: ADULT MULTI LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4947425
• MDR Text Key: 6194087
• Report Number: 1036844-2015-00333
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K970864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-16123-F
• Device Lot Number: 23F1417151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• 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