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

Catalog Number 490329

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as event two of b.Braun medical inc.(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: event 2: stopcock aspect is coming loose, and leaking blood.

Manufacturer Narrative

This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and 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 nonconformance of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: IV ADMINISTRATION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 6421624
• MDR Text Key: 70556288
• Report Number: 9614279-2017-00028
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 04046964541100
• UDI-Public: (01)04046964541100(17)190831(10)0061522726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022895
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 490329
• Device Lot Number: 0061522726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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