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

Model Number	332098
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 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 per medwatch number (b)(4): when crna was attempting to put in the catheter, she felt a slight resistance and did not continue the advancement of the catheter, and eventually decided to withdraw the catheter from the patient.It was then noticed that the blue tip/marker at the end of the catheter was not seen (approximately a centimeter) and edges seemed frayed or sheared off.Xrays were taken of lumbar spine 2-3 views, cervical spine 2-3 views and thoracic spine 2 views: no radiopaque linear density or foreign body noted (in all views).No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.The sample was visually inspected, and it was noted that the catheter appeared to be sheared or broken off.It was determined that the shearing was unlikely to have occurred during the manufacturing process, and rather that the catheter sheared during user application.The exact root cause could not be determined at this time.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.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 9580661
• Report Number: 2523676-2019-00238
• Device Sequence Number: 546364
• Product Code: OGE
• UDI-Device Identifier: 04046964177385
• UDI-Public: 04046964177385
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• 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: 332098
• Device Catalogue Number: 332098
• Device Lot Number: 0061686301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/13/2020
• 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: 21 YR
• Patient Weight: 83