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

Catalog Number	552047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: a provider was placing a labor epidural and could not advance the catheter past 12cm, and when pulling the tuohy and catheter out met resistance with the catheter.The plastic catheter was being removed when the plastic stopped and only the springwound wire was being pulled from the patient.The wire was removed and the remaining piece of plastic was still attached and they were able to remove the piece intact.
Additional Manufacturer Narrative
(b)(4).One (1) used, sample was returned in conjunction with this complaint.The sample was visually evaluated and it was confirmed that the tip of the catheter was damaged.While no specific conclusion can be drawn, incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby damaging the catheter.As indicated in the instructions for use, the catheter should not be withdrawn through the needle because of the possible danger of shearing or kinking.Review of the discrepancy management system (dsms) database performed for the aforementioned lots revealed no abnormalities or nonconformances of this nature noted during incoming, inprocess, or final product inspection.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 6420883
• Report Number: 9614279-2017-00024
• Device Sequence Number: 779978
• Product Code: OGE
• UDI-Device Identifier: 04046964665196
• UDI-Public: (01)04046964665196(17)180531(10)0061525157
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 02/21/2017

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: 05/31/2018
• Device Catalogue Number: 552047
• Device Lot Number: 0061525157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1