MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; SET, I.V. FLUID TRANSFER

Catalog Number 2112550

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Two (2) used sets without packaging was returned for evaluation.The sets were returned together for pir's (b)(4); however, the sets were not labeled and it could not be determined which pir either set belonged to.Visual examination of both sets noted the macro valve 1 was slightly turned.No other visual defects were noted.The sets were vacuum leak tested per specification with passing results.The returned set macro valve 1 was slightly turned; however, per an email received from the customer the set was used on the apex pump.Therefore, the reported defect of misaligned valve is not confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non - conformance's noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

Event Description

As reported by the user facility: it was reported that upon opening the packaging, it was noticed that a valve was skewed.No patient involvement.

• Brand Name: B.BRAUN
• Type of Device: SET, I.V. FLUID TRANSFER
• 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: 7755281
• MDR Text Key: 116219837
• Report Number: 2523676-2018-00052
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04046964656101
• UDI-Public: 04046964656101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2016

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 2112550
• Device Lot Number: 0061624249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• 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