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

Model Number	2112349
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: during compounding it was noticed that there was a loose piece of plastic inside the bag.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) compounded bag was received for evaluation.The bag was visually examined and no particulate could be seen.The solution was then filtered to check for particulate matter, and no particulate matter was found on the filter membrane.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned bag met specifications, and no particulate matter was detected.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: 9559992
• Report Number: 2523676-2019-00237
• Device Sequence Number: 2641854
• Product Code: KPE
• UDI-Device Identifier: 04046964200700
• UDI-Public: (01)04046964200700
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/17/2020

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: 2112349
• Device Catalogue Number: 2112349
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1