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

Model Number	CE17TB
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One used catheter, without packaging, was received for evaluation.The catheter was connected to a catheter connector and 10ml b-d syringe.Upon visual observation, the catheter was broken apart approximately 9 inches from the distal end (closest to catheter connector).The remaining catheter fragment (proximal tip end) measured approximately 32 inches.No portion of the catheter appeared missing and the tip was intact.The area at the fracture was smooth and angular in appearance.The observed cut on the catheter is consistent with a potential damage noted when the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through needle because of the possible danger of shearing or kinking." all available information was forwarded to the device manufacturer of the catheter.The manufacturer reviewed the batch record of the involved catheter lot, and there were no deviations or abnormalities noted.If additional pertinent information becomes available, a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: reports the epidural catheter broke at the point of the most distal taping to the patient's back.A second catheter was then placed in the patient.

• Brand Name: PERIFIX®
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6128831
• Report Number: 2523676-2016-00822
• Device Sequence Number: 783928
• Product Code: OGE
• UDI-Device Identifier: 04046964178405
• UDI-Public: (01)04046964178405(17)180131(10)0061416414
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K813186
• 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): 08/03/2015

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: 01/31/2018
• Device Model Number: CE17TB
• Device Catalogue Number: 332224
• Device Lot Number: 0061416414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2015
• Initial Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1