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

Model Number	552006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (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.
Event or Problem Description
As reported by the user facility: complaint report states that a 30 gage hypodermic needle broke off from the hub in the patient.Details of the incident, the clinician cleaned the patient's back and administered the local anesthetic (skin wheal).Upon removing the syringe, she noticed that the needle had broken off the hub of the syringe and remained in the patient's back.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used hub with a broken off needle was received for further evaluation.Based on the condition of the received sample, it was confirmed that the needle was broken off at the hub.Although the hub was returned with no needle, it did not confirm the breakage to be the result of any manufacturing process.While we are unable to confirm the root cause of the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DESIGN OPTIONS
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9665126
• Report Number: 2523676-2020-00009
• Device Sequence Number: 16269018
• Product Code: OGE
• UDI-Device Identifier: 04046964311215
• UDI-Public: 04046964311215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/26/2020

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 Expiration Date: 12/01/2020
• Device Model Number: 552006
• Device Catalogue Number: 552006
• Device Lot Number: 0061686324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR