MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX EPIDURAL NEEDLES; 22GAUGE TUOHY NEEDLE

Model Number E2230T

Device Problem Break (1069)

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

Event Date 11/04/2014

Event Type  malfunction  

Event Description

As reported by the user facility: reports during procedure on pt, the needle broke off inside the pt.The surgery was paused.A new needle was placed and the surgery proceeded.There was no pt injury.Add'l info received from the facility indicated the doctor was unable to pull out the stylet of the 22 gauge tuohy needle, as the needle was in the caudal canal.Ultimately, the head of the stylet broke.The whole needle was then replaced with a new one that did not cause any problems.The pathway was washed with a few drops of normal saline and the needle was removed.A band-aid was applied to the site.The pt tolerated the procedure well.The pt was discharged in stable condition.

Manufacturer Narrative

(b)(4).One used epidural tuohy needle assembly, with open packaging identifying the reported lot number 0061322809, was received for eval.The metal stylet was broken off approx 1/4 inch from the distal hub.The remainder of the stylet was retained in the needle cannula and was removed using pliers.Upon removal, the broken piece of the stylet appeared to be kinked/bent.There were no missing pieces observed on the stylet or needle cannula.The needle cannula did not appear damaged.The length of the needle cannula was dimensionally tested according to spec and found acceptable.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or needle material number.There are no other reports of this nature against the reported lot number.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.The sample and all available info has been forwarded to the device mfr for needle assembly.Their investigation is ongoing at this time.A follow up report will be filed when the investigation results become available.

• Brand Name: PERIFIX EPIDURAL NEEDLES
• Type of Device: 22GAUGE TUOHY NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4349602
• MDR Text Key: 5173633
• Report Number: 2523676-2014-00440
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2014

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 Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: E2230T
• Device Catalogue Number: 332171
• Device Lot Number: 0061322809
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1