MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	363032
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and 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: that foreign matter was seen in the fluid path.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A sample jar containing the cut off end of a surgical glove was returned for evaluation.In addition, a photo was also provided.Visual inspection of the provided photo was unable to confirm the defect.The returned sample was unable to confirm any defects.The reported defect is not confirmed based on the review of the provided sample and the photo.Retain samples for catalog 363032, lot 0061650665 were visually and functionally tested per specifications and no defects were noted.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).It should be noted that this follow up is being submitted as a correction.The investigation results noted a thread like object was seen inside of the burrette.The reported defect was confirmed.Although the reported defect was confirmed, a thorough investigation was unable to be performed without the actual sample to evaluate.If a sample and/or any pertinent information, becomes available a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8863811
• Report Number: 9614279-2019-00116
• Device Sequence Number: 11396447
• Product Code: FPA
• UDI-Device Identifier: 04046964294297
• UDI-Public: 04046964294297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2019

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: 10/31/2022
• Device Catalogue Number: 363032
• Device Lot Number: 0061650665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 07/22/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/23/2019; 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1