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 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.

Event Description

Upon opening the packaging, valve number one of the transfer set was observed to be misaligned.The transfer set was not used.No patient involvement or injury.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused set with packaging was returned for evaluation.Visual examination of the set noted macro valve #1 to be turned.Therefore, the reported defect was confirmed.Visual examination of the retain sample noted no visual defects.The retain sample was vacuum leak tested, per specifications, with passing results.As a result of this issue, a new vision system was developed and implemented into the apex assembly process.This vision system will alert the operator of a misaligned valve via a visual display and an audible sound if a valve is found to be improperly installed.The reported lot number was manufactured prior to this change.A 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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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
• MDR Report Key: 7774082
• MDR Text Key: 117159524
• Report Number: 2523676-2018-00056
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04046964656101
• UDI-Public: 04046964656101
• Combination Product (y/n): N
• PMA/PMN Number: K151423
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 2112550
• Device Lot Number: 0061594367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1