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

Catalog Number 2112550

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has been received for evaluation 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: it was reported that during initial setup it was discovered that four of the stickers labeling the stations for each transfer set line were placed on the incorrect lines.Specifically, the station label stickers on lines 23 and 24 were reversed, as were the stickers on lines 25 and 26.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used set with packaging and four (4) photos were returned for evaluation.Visual examination of the set noted the flags on line 23 through 26 did not match their associated port position.Flag 23 was on position number 24, flag 24 was on position 26, flag 25 was on position 23, and flag 26 was on position 25.The returned photos showed the same defect as the returned set.No other visual defects were noted.The reported defect of lines with incorrectly labeled flags was confirmed.Retain sample were pulled and visually inspection and no defects were noted.As a result of this issue, new inspection skill assessments were initiated.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 7837122
• MDR Text Key: 118899255
• Report Number: 2523676-2018-00072
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 2112550
• Device Lot Number: 0061629009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 08/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1