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

Catalog Number	2112341
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2013017 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun italy s.P.A.(manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.Note: this report is being filed as a result of further risk assessment performed by (b)(4) affairs department.The further assessment determined on (b)(6) 2017 that this type of error could cause an event that would meet the criteria for an mdr reportable event.
Event or Problem Description
As reported: the barcode labels for transfer leads 4, 5, and 6 were mislabeled.This defect was found during a demonstration no patient involvement.
Additional Manufacturer Narrative
Exemption number e2013017.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).One used set was received for evaluation.Upon visual examination, it was confirmed that the set was mislabeled.Two lines were labeled as line 3 and there was no line 5 label.This defect is the result of an error made during manual assembly.The production department was notified about the mistake, and the operators were re-trained on the proper labeling procedure.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number, however the manufacturer has initiated a corrective and preventative action in order to address issues with mislabled product.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional information becomes available, a follow up report 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 41037 ; IT 41037
• MDR Report Key: 6820072
• Report Number: 9681240-2017-00131
• Device Sequence Number: 1600489
• Product Code: LHI
• UDI-Device Identifier: 04046964200229
• UDI-Public: (01)04046964200229
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017
• Report Date (Section F): 09/13/2017

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: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 2112341
• Device Lot Number: 16M12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/13/2017