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

Catalog Number	560533
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 report number (b)(4).Event description: patient sitting for spinal anestesia, needle was introduced to skin when needle removed, a portion of needle was broken off.Epidural placed by anestesia.Stat x-ray ordered by anesthesia to be done in pacu.Md at bedside to explain complication to patient.Patient came from triage for a c-section.She had a biophysical profile (bpp) of 6/8.Hx of hep b and substance abuse.Physican attempted to place a spinal and half of the needle broke off in the patient's back.Nursing care rendered appropriately.Physician ordered a stat x-ray.The patient got an epidural and was stable.She did not feel any pain and physician explained everything to her.An x-ray was done in pacu.A neuro consult will be done.This case was reviewed in detail with physician.She states that she only passed the spinal needle once and that it was atraumatic.Denies bony contact.It was removed along with the introducer needle as one because she intended to do a continuous spinal/epidural technique due to the amount of overlying soft tissue.There is no obvious reason why this needle failed.It does not appear to be related to technique.
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 and/or lot number, a thorough investigation could not be performed.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.

• Brand Name: DESIGN OPTIONS
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9196915
• Report Number: 2523676-2019-00175
• Device Sequence Number: 13529413
• Product Code: OFU
• UDI-Device Identifier: 04046964319518
• UDI-Public: 04046964319518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/21/2019

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 Catalogue Number: 560533
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR