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

Model Number	2112407
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by user facility: a fragment of what looked like blue plastic was in the tubing between the filter and the iv bag.The user facility felt like it had come from the iv bag and not the iv set.

• Brand Name: PINNACLE
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9932618
• Report Number: 2523676-2020-00108
• Device Sequence Number: 2910747
• Product Code: KPE
• UDI-Device Identifier: 04046964200984
• UDI-Public: (01)04046964200984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073538
• 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
• Report Date (Section B): 04/07/2020

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 Model Number: 2112407
• Device Catalogue Number: 2112407
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1