MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15853

Device Problems Partial Blockage (1065); Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device sample indicates swg/catheter resistance: kinked.

Event Description

The customer reports during insertion it was not possible to advance the stylet in the catheter.It is blocked at the luer.

Manufacturer Narrative

(b)(4).The customer returned a lid stock, one guide wire, and one 3-lumen cvc catheter for evaluation.Visual examination of the guide wire revealed two kinks.Visual examination of the catheter did not reveal any defects or anomalies.The guide wire contained two kinks at 159 and 271mm from the proximal end.The length and outer diameter of the guide wire were measured and were found to be within specification.The length of the catheter body was also within specification.The returned catheter was advanced over the proximal tip of the returned guide wire in order to functionally test the components.The guide wire was able to advance through the catheter body but could not advance through the catheter juncture hub.When the guide wire was advanced from the distal extension lines it was able to fully pass through the catheter and out of the catheter distal tip.All three extension lines on the catheter were flushed with water and functioned as expected.No sign of blockage or inter lumen crossover was observed.A device history record review was performed with no relevant findings.(con't) other remarks: the reported complaint of difficulty passing the guide wire through the catheter was confirmed by complaint investigation.The returned guide wire was unable to pass through the returned catheter.Visual examination revealed the guide wire contained two kinks.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that manufacturing caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

Event Description

The customer reports during insertion it was not possible to advance the stylet in the catheter.It is blocked at the luer.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7289820
• MDR Text Key: 100779509
• Report Number: 3006425876-2018-00142
• 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
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F17L2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1