MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW PLEURA SEAL THORACENTESIS KIT; CATHETER AND TIP, SUCTION

Catalog Number AK-01000

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

Luer lock connector at the end of the tubing misshaped.Cannot connect syringe to end due to misshaped luer lock.Kit never used on or touched patient.Md caught issue after opening kit as part of procedure prep.Kit not used on patient & never touched patient.New kit opened & used.

• Brand Name: ARROW PLEURA SEAL THORACENTESIS KIT
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 6371509
• MDR Text Key: 68767756
• Report Number: 6371509
• Device Sequence Number: 0
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AK-01000
• Device Lot Number: 13F16K0255
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR