MAUDE Adverse Event Report: TELEFLEX INCORPORATED FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number IPN046497

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

Saline ampule found to be broken when kit was opened.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 13479486
• MDR Text Key: 285245191
• Report Number: 13479486
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN046497
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: 23F21L0189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2022
• Event Location: Other
• Date Report to Manufacturer: 02/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1