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

Catalog Number	363230
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
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: it was reported that the product is untwisting after connection and chemo leaked.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.In addition, two (2) open equashields identifying lots 1820686 and 1820647 and several videos were provided.Visual examination of all provided materials noted no defects.The returned set was functionally tested per specification and the reported defect of unravelling was not able to be replicated.Therefore, the exact root cause could not be determined at this time.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, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 8793619
• Report Number: 9614279-2019-00109
• Device Sequence Number: 2038819
• 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: company representative,health
• 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 Catalogue Number: 363230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/16/2019
• 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