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

Model Number	2112351
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive photos of the reported issue 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: a human hair was found in a compounding bag.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Photos of the reported issue were provided for evaluation.A hair was observed twisted around the central tube of the bag.Based on the position of the hair, it was determined that this contamination occurred during the welding phase of the tubes between the sheets of the bag.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Retain samples were also visually inspected no abnormalities or non-conformances of this nature were observed.The manufacturing personnel that were involved in this phase of production were notified and re-trained.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
• MDR Report Key: 9932703
• Report Number: 2523676-2020-00107
• Device Sequence Number: 2910748
• Product Code: KPE
• UDI-Device Identifier: 04046964200823
• UDI-Public: (01)04046964200823
• Combination Product (Y/N): N
• 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): 06/26/2020

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: 03/30/2022
• Device Model Number: 2112351
• Device Catalogue Number: 2112351
• Device Lot Number: 19D22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1