MAUDE Adverse Event Report: TELEFLEX INCORPORATED (SUBSIDIARY OF TELEFLEX INC.) ARROW; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05001-SLR1

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  malfunction  

Event Description

It is reported that when the spinal needle was opened it was cracked on the luer lock end.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED (SUBSIDIARY OF TELEFLEX INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 6858201
• MDR Text Key: 85788712
• Report Number: 6858201
• Device Sequence Number: 1
• Product Code: CAZ
• 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: Patient
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: ASK-05001-SLR1
• Device Lot Number: 23F17A0404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2017
• Date Report to Manufacturer: 08/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• 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
• Treatment: NO; NO OTHER THERAPIES