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

Catalog Number	332220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although it was reported that the sample is not available for evaluation, the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: reports states that during an attempt to place an epidural, the catheter tip broke off inside the patient.Doctor stated she attempted to thread catheter in epidural space, felt resistance.She wasn't sure if she had resistance because she was near bone or if the catheter caused.She went to remove toughey needle and catheter out together and had resistance again.At that point, she felt a pop or snap.Doctor immediately looked at tip of the catheter and saw the blue tip had broken off into the patient.Being that the patient was in labor, the doctor then started another epidural in space below initial and that one was placed successfully, patient delivered the baby successfully.Patient had cat scan and mri immediately after giving birth and the catheter tip was not located.Neurosurgery was consulted.Neurosurgery recommended no medical intervention.Patient was notified immediately at time incident occurred.

• 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: 7008209
• Report Number: 2523676-2017-00160
• Device Sequence Number: 1273046
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: 04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 12/31/2018
• Device Catalogue Number: 332220
• Device Lot Number: 0061561966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR