MAUDE Adverse Event Report: PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332221
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: it was reported that the catheter was pulled from the patient with missing tip, ct scan was negative.Possible lot numbers provided: lot number 0061763870; expiry date 01/01/2022; production date 02/01/2021.Lot number 0061761010; expiry date 01/01/2022; production date 01/11/2021.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used catheter without packaging was provided for evaluation.Visual evaluation of the sample did show the very tip of the catheter to be sheared off.The returned sample did show the catheter to be missing the tip.However, it did not confirm the incident to be related to any manufacturing or packaging process.The returned used sample did not confirm the defect to be the result of any manufacturing process.Per the manufacturers 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 shering 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." a review of the discrepancy management system (dsms) database was performed for the reported lot numbers 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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• MDR Report Key: 11840361
• Report Number: 2523676-2021-00123
• Device Sequence Number: 4635153
• Product Code: OGE
• UDI-Device Identifier: 04046964178344
• UDI-Public: 04046964178344
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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 Model Number: 332221
• Device Catalogue Number: 332221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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