MAUDE Adverse Event Report: PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	552047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 on a laboring patient, the epidural catheter tip (approximately 0.2cm) was found missing when pulled out from the touhy needle.The catheter was removed by a crna performing the procedure due to an inability to pass the catheter through the epidural tuohy needle into the epidural space.Because it would not go through, the catheter was pulled in order to re-check loss of resistance.There was no resistance when it was pulled.It likely sheared when the needle was advance forward with the catheter still inside the needle (a common practice to get the tip further into the epidural space).Clinician discussed with the patient the benign nature of the catheter, difficulty locating the broken piece (did not show up in 3-view lumbar x-ray), and difficulty with surgical removal, and the patient at this time has not request for it to be removed.No other injuries/complication have been identified at this time.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photo was provided for further evaluation.Visual evaluation of the photo showed two catheters, one with the tip that had been sheared/cut off and the other still contained the tip.Visual evaluation of the photo did not confirm the reported defect to be the result of any manufacturing/packaging process.Per the manufacturer's investigation, this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User should refer to ifu which states, ""caution: do not withdraw catheter through the needle because of the possible danger of shearing or kinking" 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: 11726743
• Report Number: 2523676-2021-00090
• Device Sequence Number: 3437910
• Product Code: OGE
• UDI-Device Identifier: 04046964665196
• UDI-Public: 04046964665196
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/23/2021

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: 01/01/2022
• Device Model Number: 552047
• Device Catalogue Number: 552047
• Device Lot Number: 0061751692
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2021
• Supplement Date Received by Manufacturer: 04/17/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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
• Patient Age: 28 YR