MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

The customer reports that the catheter was torn during use on a patient and solution leaked from the damaged site.The catheter was removed and a new one was inserted successfully.

Manufacturer Narrative

(b)(4).The customer returned one cvc catheter for evaluation.The catheter body was separated from the rest of the catheter.The box clamp and sutures were located on the separated portion of the catheter.The points of separation on the catheter body appeared smooth, indicating that they were cut with a sharp object.The returned catheter body was separated into two pieces measuring to be 61 mm and 163 mm which in total measured to be 224 mm, within specifications of 207-227 mm per product drawing.The returned catheter portion was first tested by occluding the distal end of the catheter body and injecting liquid into each extension line using a lab inventory syringe.No leaks were detected.The catheter was again tested using a lab leak tester.The catheter was attached to the leak tester and pressurized to 300 kpa for 30 seconds.No leaks were detected.A device history record review was performed based on a potential lot with no relevant findings.The ifu provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of catheter torn during use could not be confirmed by complaint investigation.The returned catheter was cut into two pieces, as stated by the customer, but no other defects or anomalies were observed.The catheter passed all relevant dimensional testing.Full functional testing could not be performed as the catheter was cut and damaged upon receipt.A device history record review was performed using a potential lot with no relevant findings.Based on the sample received, the probable cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the catheter was torn during use on a patient and solution leaked from the damaged site.The catheter was removed and a new one was inserted successfully.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the catheter was torn during use on a patient and solution leaked from the damaged site.The catheter was removed and a new one was inserted successfully.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7630234
• MDR Text Key: 112181533
• Report Number: 3006425876-2018-00413
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/19/2019
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F17K1349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1