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

Model Number	2112341
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported by user facility: we went to use one of the tpn and it had two number three lines and no 4.
Additional 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
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11403931
• Report Number: 2523676-2021-00045
• Device Sequence Number: 11830885
• Product Code: LHI
• UDI-Device Identifier: 04046964200229
• UDI-Public: (01)04046964200229
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1