MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030863

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the catheter was pierced at its end.A hole was noted on the catheter during use.The staff removed it and replaced it.

Event Description

The customer reports: the catheter was pierced at its end.A hole was noted on the catheter during use.The staff removed it and replaced it.

Manufacturer Narrative

(b)(4).Customer returned one 3-l cvc catheter for evaluation.Initial visual inspection of the catheter did not reveal any obvious defects or deformities.The skive holes on the catheter tip appears as expected.After failing function inspection, a hole was found on the catheter body adjacent to the juncture hub.The hole is consistent with an undue lateral force being applied to the catheter body, potentially during sample return to the morrisville facility.Since the customer stated, "the catheter was pierced at its end" it does not appear that they were reporting this defect.The customer also did not mention leaking in the catheter so it is likely this defect occurred after use by the customer and is not the customer reported defect.No other defects or anomalies were observed on the catheter.The overall length of the catheter body measured 165 mm which is within specification of 158.5-175 mm per product drawing.The returned catheter had all 3 lumens flushed.The catheter body only leaked from the identified hole near the juncture hub on the medial line.The other extension lines functioned as expected.The customer did not provide a lot number, however, a potential lot was determined based on a sales history review for this customer.A dhr review was completed based on the potential lot with no relevant findings.The instructions for use(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 a hole in the distal end of the catheter body was not able to be confirmed through evaluation of the returned sample.The "hole" the customer was most-likely reporting was a skive which is an intentional hole in the catheter body; not a defect.A dhr review was completed based on sales history with no relevant findings.The catheter also passed dimensional inspection.Based on the condition of the returned sample and the customer report, no problem was found on the device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10295117
• MDR Text Key: 199533217
• Report Number: 3006425876-2020-00629
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1