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

Catalog Number	2112342
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2018
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.Additional attempts to receive the sample 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: transfer set is leaking lipids into the other lines.No patient involvement.
Additional Manufacturer Narrative
Exemption number e2013017.(b)(4).The actual device involved in the reported incident was not returned for evaluation.A photo was provided, that showed a milky solution in a bag in comparison with a lipid solution and a clear solution in two additional bags.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Although no samples were provided for this report, one used set was received from a different batch number from the same user facility for evaluation under internal report number (b)(4).After flushing the set to remove any particulate that may have formed while the set was stored and transported, the set was flow tested and no issues were detected.The set was then dissected to evaluate the valve on the lead reported to be experiencing the backflow issue.No structural defects were found, and the valve met product specifications.Review of the device history record 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.A form 3500a was filed for internal report (b)(4), under mfr report # 9681240-2018-00006.

• 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: 7635171
• Report Number: 9681240-2018-00008
• Device Sequence Number: 1754318
• Product Code: LHI
• UDI-Device Identifier: 04046964200311
• UDI-Public: (01)04046964200311
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018
• Report Date (Section F): 08/10/2018

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: 11/30/2022
• Device Catalogue Number: 2112342
• Device Lot Number: 17M12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2018
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 08/10/2018