MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT

Catalog Number	332078
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
Per medwatch: (b)(4).Event 1: event: three attempts were made at inserting an epidural catheter at l3-l4 level.On the third attempt, the catheter was passed into what appeared to be the epidural space, based on the loss of resistance.After the catheter was passed to 12 cm, the patient complained of pain on the left side, while at the same time, i encountered resistance to passing the catheter further.I then stopped passing the catheter further and began pulling back the catheter and the needle.Immediately after starting to pull back, the catheter became loose and i noted that the tip of the catheter broke at approx.3.5 cm and was retained in the patient.The procedure was then aborted and the patient immediately delivered without complications and without an epidural catheter.She remained neurologically intact.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6446114
• Report Number: 2523676-2017-00035
• Device Sequence Number: 13597873
• Product Code: OGE
• UDI-Device Identifier: 04046964177200
• UDI-Public: (01)04046964177200(17)180430(10)0061520990
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 332078
• Device Lot Number: 0061520990
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 105