MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	363032
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: "there is some form of substance on the spike." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample and one (1) photo was returned in connection to this complaint.Upon visual examination, it was noted that a reddish-brown colored substance was on the end of the spike.The substance was able to be wiped off.Therefore, the reported defect was confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.The sample was forwarded to the supplier for further investigation.Per the supplier investigation, the substance was found to be embedded burnt material in the plastic, which is a cosmetic issue that occasionally happens during manufacturing.A potential rot cause could be the cleaning of the air exhausts of the mold.All available information regarding this occurrence has been forwarded to our mrb business unit leaders and all personnel involved in the manufacturing and inspection of this product in order to heighten awareness.Additionally, all information concerning this reported incident has been included in our trend analysis of the product line.We continuously monitor product incident reports to identify trends which might affect the quality of our products.We will maintain this report for future reference, and continue to monitor other reports for similar occurrences.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8646207
• Report Number: 9614279-2019-00082
• Device Sequence Number: 1941796
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 05/22/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1