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

Catalog Number	333512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.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 report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by user facility: the patient received an obstetrical epidural installation for labor delivery.The epidural catheter broke during removal which caused a piece, about 5cm in size, of the membrane to be left in the patient.The patient had the piece surgically removed post labor delivery.No complications occurred during the surgical procedure to remove the catheter piece.Patient status is fine.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformance of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Additional Manufacturer Narrative
(b)(4).One (1) catheter without packaging was returned in connection with this complaint.Visual examination of the returned sample shows the distal tip of catheter to be broken off.According to the quality engineer, the cut of the jacket matches the geometry of the cannula's inside bevel.Therefore, it was concluded that this defect did not happen during the manufacturing process.Per the instructions for use (ifu), "when removing catheter, excessive force should never be applied.If catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." the reported defect was not confirmed.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.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
• Manufacturer (Section D): B. BRAUN MEIDCAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7007837
• Report Number: 2523676-2017-00158
• Device Sequence Number: 900896
• Product Code: OGE
• UDI-Device Identifier: 04046963899202
• UDI-Public: 04046963899202
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 333512
• Device Lot Number: 0061450494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017; 10/18/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/04/2017; 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention