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

Model Number 2112341

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: we went to use one of the tpn and it had two number three lines and no 4.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) sample was received for evaluation.When the sample was visually inspected it was observed that two leads were labeled as line 3, and there was no line 4 label.This error was the result of human error during manual assembly.The appropriate personnel have been re-trained on the correct process in order to prevent future occurrences of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11403931
• MDR Text Key: 234456151
• Report Number: 2523676-2021-00045
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 04046964200229
• UDI-Public: (01)04046964200229
• Combination Product (y/n): N
• PMA/PMN Number: K041222
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2112341
• Device Catalogue Number: 2112341
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1