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

Catalog Number	2112342
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.
Event or Problem Description
As reported by user facility: transfer sets are labeled backwards, from left to right the leads are labeled 9, 8, 7, 6, 5, 4, 3, 2, 1, instead of 1, 2, 3, 4, 5, 6, 7, 8, 9.No patient involvement.
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 set was received for evaluation.When the set was visually inspected the reported issue was confirmed; the lead lines were reversed with respect to the tubing sequence of the manifold.The cause of this defect was a human error which occurred during the manufacturing process.An employee did not use a poka-yoke tool that was designed to guide the assembly operator in the correct sequence of the lead lines.Re-training of all of the operators responsible for this step of the assembly was done, in order to emphasize the importance of the correct sequence of assembly using the poka-yoke tool.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances 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.

• 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: 8254201
• Report Number: 9681240-2019-00001
• Device Sequence Number: 2418347
• Product Code: LHI
• UDI-Device Identifier: 04046964200311
• UDI-Public: (01)04046964200311
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019
• Report Date (Section F): 02/25/2019

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: 06/30/2023
• Device Catalogue Number: 2112342
• Device Lot Number: 18G03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/02/2019
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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: 02/25/2019