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

Catalog Number	333853
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the customer has confirmed that a sample is not available for evaluation, the investigation is ongoing at this time.The event necessitated surgical intervention to prevent potential impairment of body function or permanent damage to body structure.Attempts were made to obtain more information without success.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: "'in the labor and delivery unit, a spinal needle "broke off" in a patient.The patient will be going to surgery to have the broken off portion removed.'" no follow-up information available as of 05/20/2019.
Additional Manufacturer Narrative
No samples were returned for evaluation.Without the actual device, a thorough investigation could not be performed.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.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4): note: this follow-up is being filed to provide additional information, as a sample was received from the end customer.One (1) unidentifiable bent piece of a needle was returned for evaluation.While this confirms the report of a broken needle, no specific conclusions can be made regarding the cause of the reported event.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.A review of the batch history records was also performed and no non-conformances or deviations were noted.

• Brand Name: PENCAN®
• Common Device Name: NEEDLE, CONDUCTION, ANESTH
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 861 marcon boulevard; allentown PA 18109
• MDR Report Key: 8624388
• Report Number: 2523676-2019-00064
• Device Sequence Number: 2259773
• Product Code: BSP
• UDI-Device Identifier: 04046964180644
• UDI-Public: 04046964180644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 333853
• Device Lot Number: 0061618036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 05/01/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/17/2019; 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention