MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN®; NEEDLE, CONDUCTION, ANESTH

Catalog Number	333877
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by user facility: the b.Braun spinal needle broke at the connection between the needle and the hub.The needle break occurred as the stylet was being removed from the spinal needle which was inserted in the epidural needle as part of the cse technique.No patient injury, as this occurred during a demonstation.
Additional Manufacturer Narrative
(b)(4).No samples were returned for evaluation in connection with this incident; however, one (1) picture was returned.The picture returned by the facility shows one spinal needle without packaging and one stylet without packaging.The picture and all available information were forwarded to the manufacturer for further investigation.Per the manufacturer's investigation, the defect could not be confirmed since no sample was returned and the batch number was unknown.Visual examination of the picture showed the needle coming out the bevel side.Strength tests on the hub and cannula were performed on ten (10) batches from the last three years and no abnormalities were observed.Although a picture was provided, it did not clearly depict the reported defect.Further investigation is not possible without the actual sample.Without the actual device, a thorough investigation could not be performed.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was reported as unknown.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PENCAN®
• Common Device Name: NEEDLE, CONDUCTION, ANESTH
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7190083
• Report Number: 2523676-2017-00181
• Device Sequence Number: 111271
• Product Code: BSP
• UDI-Device Identifier: 04046963069568
• UDI-Public: 04046963069568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K932569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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 Catalogue Number: 333877
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1