MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-16553-E

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: during catheter use, the lumen was occluded, when the lumen is verified a leak of liquid was evidenced in the base of the catheter (blue butterfly).The device was replaced.

Event Description

The customer reports: during catheter use, the lumen was occluded, when the lumen is verified a leak of liquid was evidenced in the base of the catheter (blue butterfly).The device was replaced.

Manufacturer Narrative

(b)(4).The customer returned one three lumen cvc and a 10 ml syringe for evaluation.Visual examination of the sample revealed a hole on the left side of the juncture hub.The hole was flared out, indicating that excessive pressure caused the hub to burst.Signs-of-use in the form of adhesive residue was also observed on the extension lines.No other defects or anomalies were observed.The catheter was functionally tested by injecting water into all three extension lines using a lab inventory syringe.When injecting the proximal lumen, water leaked from the hole in the juncture hub.No leaks were observed when injecting through the other two lumens.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit cautions the user, "use of a syringe smaller than 10 ml to irrigate or declot an occluded catheter may cause intraluminal leakage or catheter rupture." the reported complaint of a "juncture hub leak in use" was confirmed by complaint investigation of the returned sample.The catheter contained a small hole in the back of the juncture hub.The hole was flared out , indicating excessive force caused the hub to burst.Functional inspection revealed that the water leaked form the juncture hub when injecting water through the proximal lumen.A device history record review was performed with no relevant findings to suggest a manufacturing issue.Based on the sample received and the customer description, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8464138
• MDR Text Key: 140310379
• Report Number: 9680794-2019-00111
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CS-16553-E
• Device Lot Number: 14F18C0497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 15