MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOM SPINAL KIT; EPIDURAL ANESTHESIA KIT

Lot Number 6318

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 05/30/2018

Event Type  Injury  

Event Description

Young female at (b)(6) gestation was scheduled for mcdonald cerclage with bladder flap dissection procedure due to history of asymptomatic cervical dilation in prior pregnancies.Spinal placed by anesthesia; no complications noted in the procedure note.Per the operative report, the patient had continued pain despite the spinal block.Per anesthesia report, spinal kit bupivacaine did not work completely, resulting in an inadequate level of anesthesia.General anesthesia was required to complete the procedure.Following initiation of general anesthesia, the procedure was completed without further complication.Manufacturer response for custom spinal kit, b.Braun (per site reporter).B.Braun was notified of this issue as it has happened more than once since start of this year.There have been multiple discussions between b.Braun, anesthesia and the materials processing department of facility.Facility removed the lot # from stock, and has now worked with b.Braun to remove the medication from the kit completely in an effort to prevent this type of event.Facility has continued concern regarding temperature management prior to the kits arriving and has shared these concerns with b.Braun.

• Brand Name: CUSTOM SPINAL KIT
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7666068
• MDR Text Key: 113333074
• Report Number: 7666068
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 6318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7300 DA
• Patient Weight: 52