MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Catalog Number 456003

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The initial reporter confirmed that no samples were available for evaluation in connection with this incident.The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.

Event Description

It was reported that at the end of the manufacturing process a particulate was observed in the final product bag.Since the defect was not observed until the end of the manufacturing process, all components used are being investigated.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Three (3) pictures were supplied by the customer.It should be noted that these pictures did not show the b.Braun stopcock.The pictures were evaluated per specification.The pictures showed a particulate inside a bag of clear fluid.The bag in the picture is not a b.Braun product.One picture showed a magnified view of the particulate.However, since the stopcock was not pictured, the defect could not be confirmed.Without the actual device, a thorough investigation could not be performed.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.We will maintain this report for future reference and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DISCOFIX®
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 8379133
• MDR Text Key: 138409126
• Report Number: 2523676-2019-00003
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964183577
• UDI-Public: 04046964183577
• Combination Product (y/n): N
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 456003
• Device Lot Number: 17C2892041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1