MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Catalog Number	552122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
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): event description: a.B.Braun 19 gauge epidural catheter was placed without difficulty in an obstetrics (ob) patient during labor for pain management.The placement was uneventful and the catheter was taped, test dosed and bloused as per routine protocol.There was nothing remarkable about the placement of the catheter.Approximately 90 minutes after the catheter was placed, the patient was sitting up in bed with the assistance of her nurse and they heard a snap.The nurse quickly identified that the epidural catheter snapped apart/shredded and immediately call the ob anesthesia attending physician and the ob anesthesia.On inspection, it appeared that the plastic sheath covering the spring wire broke into two pieces.Fortunately the spring wire was completely intact and the epidural/wire were easily removed with no concerns of a retained catheter or spring.The patient was concerned that the catheter broke with minimal force during a patient position change.A new epidural catheter was placed without complications.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned in connection with this complaint.However, a picture of a 19g spring wound catheter was provided.Visual examination of the returned picture noted the catheter was broken and the spring uncoiled out of the tubing.Although the reported defect was confirmed via visual examination of the returned picture, the exact root cause is not determined at this time.A 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 future reference, and continue to monitor other reports for similar occurrences.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7791874
• Report Number: 2523676-2018-00062
• Device Sequence Number: 1517779
• Product Code: OGE
• UDI-Device Identifier: 04046955056842
• UDI-Public: 04046955056842
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/18/2018

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: 08/31/2019
• Device Catalogue Number: 552122
• Device Lot Number: 0061605305
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 61