MAUDE Adverse Event Report: PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
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: "during placement of the epidural catheter with products 333161 and epidural tray 332282, the 20g catheter from the tray went into the spinal needle hole in the tuohy from 333161.The catheter could not be advanced and the entire setup was removed together.When removed, it was noted that the catheter tip was in the spinal hole.An x-ray was done but we could not find the catheter tip.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photo was provided for evaluation.Visual evaluation of the photo confirmed packaging from the two reported items and lot numbers.The photo also shows a catheter advanced through a toughy needle and it appears that the tip had been sheared off.However, it could not confirm the reported incident to be a manufacturing defect.The provided picture does not offer the details necessary to confirm the reported defect or determine any root cause at this time.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process of the needle or catheter.It is believed to happen during application.User should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." 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.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
• MDR Report Key: 11435113
• Report Number: 2523676-2021-00060
• Device Sequence Number: 3287199
• Product Code: OGE
• UDI-Device Identifier: 04046964178948
• UDI-Public: 04046964178948
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/25/2021

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: 06/01/2021
• Device Model Number: 332282
• Device Catalogue Number: 332282
• Device Lot Number: 0061723905
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1