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	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that the end user has two (2) possible batch numbers.The possible batch numbers are: batch number: 0061639395, production date: 10/24/2018, expiry date: 04/30/2020.Batch number: 0061634151, production date: 10/18/2018, expiry date: 04/30/2020.
Event or Problem Description
As reported by the user facility: event 1: it was reported that the 20g polyamide catheter snapped in half during use.No injury reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).One (1) used closed tip catheter attached to a catheter connector was returned for investigation.Visual examination of the returned sample revealed that the connector was stretched and broken in half.Therefore, the reported defect is confirmed.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.Although the reported defect was confirmed, the exact cause was not determined at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 8359507
• Report Number: 2523676-2019-00004
• Device Sequence Number: 11191849
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: 04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 332220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR