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

Catalog Number	530155
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 reported by the user facility: the blue tip of the epidural catheter broke off within a patient during use.The clinician was removing the catheter when resistance was met.When the catheter was pulled and removed, the tip was not intact.A ct was performed, but the tip was not seen on imaging.The patient has normal vitals and a normal neurological assesment at the time of the incident.The facility will continue to monitor the status of the patient.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned in connection with this complaint.However, a picture was submitted that depicts the defect.Visual examination of the picture notes that the catheter is stretched out and the tip is broken off.However, per the customers report, "the clinician was removing the catheter when resistance was met.The catheter was pulled on and when removed the tip was not intact", "placing catheter back through the needle causing tip of the catheter to shear".User should refer to ifu which states, "when removing catheter, excessive force should never be applied.If catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." and "do not withdraw the catheter through the needle due to the possibility of shearing or kinking".User should refer to ifu which states, "when removing catheter, excessive force should never be applied.If catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." and "do not withdraw the catheter through the needle due to the possibility of shearing or kinking".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: DESIGN OPTIONS®
• Common Device Name: SPINAL EPIDURAL ANESTHESIA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8603384
• Report Number: 2523676-2019-00036
• Device Sequence Number: 2359641
• Product Code: OFT
• UDI-Device Identifier: 04046964306211
• UDI-Public: 04046964306211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/28/2019

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: 06/30/2020
• Device Catalogue Number: 530155
• Device Lot Number: 0061661794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: Other