MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; NERVE BLOCK TRAY (KIT)

Catalog Number	332100
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 customer opened a tray and the syringe had a liquid substance inside that smeared when the plunger was moved.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400430109.One (1) used tray with packaging was returned for evaluation.Inside of the tray in a plastic bag was an ops 20ml perfusor syringe.Visual examination of the returned 20ml syringe notes that the liquid present inside is excess silicone.No other defects are present on the syringe.The defect of excess silicone on the inside of the syringe is confirmed.Due to previous complaints for the same issue, our internal document was updated with pictures and instructions to clarify the handling of the plunger tips.Additionally, pictures of unacceptable syringes were also added.This document became effective on 2019-04-26.Since this lot was produced before this change, no further actions will be taken at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.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.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: B.BRAUN
• Common Device Name: NERVE BLOCK TRAY (KIT)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8612022
• Report Number: 2523676-2019-00061
• Device Sequence Number: 19333922
• Product Code: OGJ
• UDI-Device Identifier: 04046964177408
• UDI-Public: 04046964177408
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/29/2019

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 332100
• Device Lot Number: 0061637305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1