MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STOPCOCK, I.V. SET; IV ADMINISTRATION SET

Catalog Number 7S1300

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although it was confirmed that the device would not available for evaluation, a batch number was provided 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: as an 18mm amplatzer amulet (acp2) was being rinsed and prepped for implant, the associated hemostasis valve was observed to be leaking.No patient injury.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The actual device was not received for further evaluation; however, five (5) retain samples were pulled and tested.The five house retain were visually examined with no defects noted.The five retains were luer, free passage, and pressure tested with passing results.The reported defect of leakage was not confirmed.Since a sample was not returned for evaluation, a thorough investigation could not be performed at this time, and the exact root cause of this incident could not be determined.No specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: STOPCOCK, I.V. SET
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 6817977
• MDR Text Key: 83747792
• Report Number: 2523676-2017-00121
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 7S1300
• Device Lot Number: 0061460125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 07/28/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1