MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. EPIDURAL TRAY; NEEDLE

Device Problem Break (1069)

Patient Problem Scar Tissue (2060)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

As reported by the pt: event was reported by the pt for an epidural needle breaking off during the procedure.The pt stated that the needle had broken off during labor and had to be surgically removed.This left a scar that is 2-3 inches.The pt also indicated that the hospital was going to perform an investigation into this, but after multiple follow-up attempts, the hospital gave the pt the name of the mfr of the needle (b.Braun).The pt did not have a contact name for the hospital and has not heard anything further from the hospital.This issue was not previously reported to b.Braun by the hospital.

Manufacturer Narrative

(b)(4).A follow-up call was made to the facilities risk management department to obtain additional info regarding this event.The risk manager clarified that it was not the epidural needle that broke off, but rather the smaller needle that's used to deaden/numb the area before insertion.The doctor felt it was best to remove the fragment, but there was no pt injury as a result.The fragment was successfully removed.The risk manager stated that the facility did not report the incident because the incident was not considered reportable under the safe medical device act.A sample is not available to be returned, and the item and lot number is unk.No additional info is available.Without the actual sample or lot number, a thorough eval could not be performed and no specific conclusions can be drawn.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: EPIDURAL TRAY
• Type of Device: NEEDLE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4360383
• MDR Text Key: 5118819
• Report Number: 2523676-2014-00450
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/21/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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