MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE®; CONTAINER, I.V.

Model Number	2112348
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event one of 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: event 1.White plastic particulate found in fluid.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as event one of b.Braun medical inc.Internal report number (b)(4).Two (2) unused bags were received for evaluation.Upon visual inspection by the naked eye, white particles were detected in each sample.These particles were identified as being compatible with eva material under ft-ir analysis.There is a component of the bag assembly that is made from eva material.As a result, the component of the bag made from eva material could not be excluded as the source of the contamination.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.There were no product deviations, and the particle could not be attributed to the production process.A traceability search was performed, and 3 subassembly batches using the eva material were used in the manufacturing of this final product batch.In all 3 subassembly batches the same batch of eva material was used.The eva material is purchased from an approved supplier and goes through an incoming inspection before being used in production.The supplier of the eva material was notified of this report.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE®
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9446041
• Report Number: 2523676-2019-00232
• Device Sequence Number: 11370554
• Product Code: KPE
• UDI-Device Identifier: 04046964200670
• UDI-Public: (01)04046964200670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• 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): 01/28/2020

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: 04/29/2022
• Device Model Number: 2112348
• Device Catalogue Number: 2112348
• Device Lot Number: 19E16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1