MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SPINOCAN®; NEEDLE, CONDUCTION, ANESTH

Catalog Number 333313

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2019

Event Type  malfunction  

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 Description

As reported by the user facility: event 1: description of issue: black, sticky substance noted on the inside of 2 needles.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused spinocan needle with packaging was returned for evaluation.The sample was visually inspected and foreign material was identified in the packaging.Retained units for batch number 0061681018 were inspected, and no defects were noted.Although the reported defect was confirmed, the exact root cause was unable to be determined.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.If any additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: SPINOCAN®
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9295124
• MDR Text Key: 177963863
• Report Number: 2523676-2019-00214
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04046964833229
• UDI-Public: 04046964833229
• Combination Product (y/n): N
• PMA/PMN Number: K820047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 333313
• Device Lot Number: 0061681018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1