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

Catalog Number	363230
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2019
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: event 2: the male equashield connector released from the ultrasite valve, causing chemo leakage.No injury reported.
Additional Manufacturer Narrative
This report has been identified as event 2 of b.Braun medical internal report number (b)(4).One (1) used sample, photos, and videos were returned for evaluation.In addition, three (3) equashields were returned, one attached to the proximal ultrasite valve.Alcohol caps were also noted to be attached to the middle and distal valves.Visual examination of the returned samples noted no defects.Therefore, the reported defect was not 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.In addition, extensive engineering test report (etr) testing examined the use and misuse of unraveling through multiple factors including excess silicone, presence of alcohol vs no alcohol, and various degrees of torque to tighten connection.The reported defect was unable to replicated.Also, etr testing examined the interaction between returned ultrasite valves with equashield adapters, ultrasite valves with unopened equashield adapters, the presence of wet vs dry conditions, and cleaned vs uncleaned valves per the ifu.During testing, two instances of unraveling were observed.However, no defects were able to be observed on the returned ultrasite valves.A possible defect was noted on the unopened equahsield adapter threads that could possibly contribute to the unravelling.The equashield adapters returned with the complaints had fine strands of plastic noted on the threads.When an equashield with the possible defects was connected and disconnected with an ultrasite valve, similar fine strands were observed.The equashield adapters have been sent to the manufacturer for further investigation.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 8674567
• Report Number: 9614279-2019-00091
• Device Sequence Number: 19642369
• Product Code: FPA
• UDI-Device Identifier: 04046964294495
• UDI-Public: 04046964294495
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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): 11/27/2019

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: 02/29/2024
• Device Catalogue Number: 363230
• Device Lot Number: 0061669507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1