MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE; SET, I.V. FLUID TRANSFER

Model Number	2112341
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event 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 in (b)(4): foreign particle found.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number 400498535.One (1) sample was returned for evaluation.A hair was found inside the packaging, but not in the device or in the fluid path.This contamination could have occurred during the final packaging of the product.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.House retain samples from the reported lot number were evaluated and did not reveal any abnormalities or non-conformances of this nature.Based on the investigation information, the manufacturer determined that this is an isolated incident and no further action beyond notifying production personnel will be taken at this time.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11178766
• Report Number: 2523676-2021-00014
• Device Sequence Number: 19543300
• Product Code: LHI
• UDI-Device Identifier: 04046964200229
• UDI-Public: (01)04046964200229
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 02/28/2025
• Device Model Number: 2112341
• Device Catalogue Number: 2112341
• Device Lot Number: 20C04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1