MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number JP-17702-C

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device (catalog#) is not intended for sale in the us.Similar device sold in the us.

Event Description

It was reported that when a user attempted to puncture in the patient using a needle.Air leak from needle.Sample was discarded.As a result, a new kit was opened for patient use.

Event Description

It was reported that when a user attempted to puncture in the patient using a needle.Air leak from needle.Sample was discarded.As a result, a new kit was opened for patient use.

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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7573678
• MDR Text Key: 110228936
• Report Number: 3006425876-2018-00371
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: JP-17702-C
• Device Lot Number: 71F17G0355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1