MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFSITE®; SET, ADMINISTRATION, INTRA

Model Number	415069
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number: (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was detected that a safe site 19g needle (product code: 415069) when the outer packaging was removed that there was a white hard substance on the needle of the device.There was nothing present on the needle sheath or the outer packaging.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) pictures were provided for further evaluation.The photos and all available information were forwarded the supplier for further evaluation.Based on the supplier's response, three photos show a needle with no plastic shield and an epoxy drip around the middle of the needle.No other defects or imperfections were observed.The supplier stated that this type of defect could occur during the assembly process.Verification of the cannulation was performed.The settings were correct, and the flow of the product was good.To date, there have been no similar events reported for this lot.Based on the investigation and the photo sample analysis the defect reported by the customer was confirmed.A device history record review was completed for the provided material number and lot number.The review did not reveal any defect quality issues during the production of this lot that could have contributed to the reported defect.While the exact root cause was not determined, we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: SAFSITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15205893
• Report Number: 2523676-2022-00391
• Device Sequence Number: 2123922
• Product Code: FPA
• UDI-Device Identifier: 04022495769879
• UDI-Public: (01)04022495769879
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K942988
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 09/30/2025
• Device Model Number: 415069
• Device Catalogue Number: 415069
• Device Lot Number: 0061752353
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown