MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW-CLARKE PLEURA-SEAL THORACENTESIS KIT; CATHETER AND TIP, SUCTION

Catalog Number AK-01000

Device Problems Kinked (1339); Device Packaging Compromised (2916); No Flow (2991)

Patient Problem No Information (3190)

Event Date 03/01/2017

Event Type  malfunction  

Event Description

Drain tubing kinked in thoracentesis tray due to manufacturer's improper packaging.Tubing is always laying across the raised part of a syringe that causes tubing to be compressed and kinked, not allowing any flow.Checked a few packages from the lot number 13f16l0141 exp 6/30/2018.All packages had same issue.So tried a different lot number of 13f16l0020 and same defect was discovered making them non-usable.Already returned a separate lot number earlier and notified manufacturer.(13f16k0256).

• Brand Name: ARROW-CLARKE PLEURA-SEAL THORACENTESIS KIT
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 6383418
• MDR Text Key: 69220074
• Report Number: 6383418
• Device Sequence Number: 1
• 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: 03/03/2017,03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: AK-01000
• Device Lot Number: 13F16L0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 79