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

Catalog Number	2112342
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).One used set was received for evaluation.Upon visual examination the reported event was confirmed; the labels for line 8 and line 9 were switched.This defect is the result of an error made during manual assembly.The production department was notified about the mistake and trained on the proper labeling procedure.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.If additional pertinent information becomes available a follow-up report will be filed.Note: this report is being filed as a result of further risk assessment performed by b.Braun's medical affairs department.The further assessment determined on 18 aug 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 by user facility: the barcode labels for the #8 lead tube and the #9 lead tube were switched.No patient injury.

• 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: 6820073
• Report Number: 9681240-2017-00130
• Device Sequence Number: 16541480
• Product Code: LHI
• UDI-Device Identifier: 04046964200311
• UDI-Public: (01)04046964200311
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2017
• Report Date (Section F): 08/25/2017

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: No Information
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 2112342
• Device Lot Number: 17B20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/25/2017
• 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: 08/25/2017