MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Lot Number 23F17F0491

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

Patient (pt) admitted for induction of labor on [date redacted].Pt requested elective labor epidural for pain management.Epidural catheter placed next day at 1133 without difficulty.Pt delivered infant on that day at 1352, registered nurse (rn) attempted to remove epidural catheter after delivery and noted that it was difficult to remove.Rn called anesthesiologist who evaluated patient and attempted to remove epidural catheter.Anesthesiologist noted that epidural catheter was beginning to separate.Epidural catheter was removed after traction was applied.No injury to patient noted.Epidural catheter noted to be stretched and a different consistency in two locations.

Manufacturer Narrative

The following elements have blank data.

Event Description

Patient (pt) admitted for induction of labor on [date redacted].Pt requested elective labor epidural for pain management.Epidural catheter placed next day at 1133 without difficulty.Pt delivered infant on that day at 1352, registered nurse (rn) attempted to remove epidural catheter after delivery and noted that it was difficult to remove.Rn called anesthesiologist who evaluated patient and attempted to remove epidural catheter.Anesthesiologist noted that epidural catheter was beginning to separate.Epidural catheter was removed after traction was applied.No injury to patient noted.Epidural catheter noted to be stretched and a different consistency in two locations.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 6960938
• MDR Text Key: 89811132
• Report Number: 6960938
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Lot Number: 23F17F0491
• Other Device ID Number: K-05500-112A(12/08)
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2017
• 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