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

Model Number	332254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: event 2: it was reported that the needle broke.No injury reported.
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical internal report number (b)(4).One (1) photo was provided for evaluation.Visual examination showed the open tray and needle were severely bent.It should be noted that the bend in the tray corresponds with the bend in the needle.Based on the photo evaluation, it was determined that this defect is not the result of any manufacturing or packaging process.The batch record and our discrepancy management system database could not be reviewed as a lot number was not provided.Based on the data from our evaluation, no specific conclusions can be made regarding the cause of the reported event.

• Brand Name: PERIFIX
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10199706
• Report Number: 2523676-2020-00182
• Device Sequence Number: 11024261
• Product Code: OGE
• UDI-Device Identifier: 04046964178788
• UDI-Public: 04046964178788
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Model Number: 332254
• Device Catalogue Number: 332254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1