MAUDE Adverse Event Report: B. BRAUN AVITUM ITALY S.P.A. PINNACLE®; SET, I.V. FLUID TRANSFER

Model Number	2112342
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	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: it was reported that the lead label was incorrect.As reported by the customer, "the device has two same numbers." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The affected device was provided for further evaluation.Visual inspection confirmed two #8 labels were found, one of them in place of #9 which was found to be missing.The reported defect as confirmed.Based on the evaluation performed, the defect derives from an accidental human mistake happening during the manual assembly.As a result of this occurrence, retraining was performed.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: PINNACLE®
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola modena, 41037 ; IT 41037
• Manufacturer (Section G): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola modena, 41037 ; IT 41037
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15853336
• Report Number: 9681240-2022-00005
• Device Sequence Number: 6429229
• Product Code: LHI
• UDI-Device Identifier: 04046964200311
• UDI-Public: (01)04046964200311
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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 Expiration Date: 12/31/2025
• Device Model Number: 2112342
• Device Catalogue Number: 2112342
• Device Lot Number: 21A12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown