MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN MINIBORE TRI-FUSE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP9220-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 7-in minibore tri-fuse set leaked.The following information was provided by the initial reporter: material no: mp9220-c ; batch no: 20035960 it was reported that there was a leakage where the tubing connects to the clave.Event description per email states: product description: tri-fuse ext set.Manufacturer name: bd damage xleak break.Was there an injury or death? y n.If yes, complete an epso report and quarantine equipment according to policy gen-015.Date incident occurred: (b)(6) 2020.Is product quarantined y n.Equipment: med watch completed? y (.) details of issue: leaking where the tubing connects to the clave, some are not creating a good seal.
Event or Problem Description
It was reported that 7-in minibore tri-fuse set leaked.The following information was provided by the initial reporter: material no: mp9220-c batch no: 20035960 it was reported that there was a leakage where the tubing connects to the clave.Event description per email states: product description: tri-fuse ext set manufacturer name: bd damage xleak break was there an injury or death? y n if yes, complete an epso report and quarantine equipment according to policy gen-015 date incident occurred: (b)(6) 2020 is product quarantined y n equipment: med watch completed? y (.) details of issue: leaking where the tubing connects to the clave, some are not creating a good seal.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The root cause of this failure could not be identified without a failure investigation.A device history record review for model mp9220-c lot number 20035960 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.See h.10.

• Brand Name: 7-IN MINIBORE TRI-FUSE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10694560
• Report Number: 9616066-2020-20096
• Device Sequence Number: 3141252
• Product Code: FPA
• UDI-Device Identifier: 50885403237001
• UDI-Public: 50885403237001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: Other
• Device Expiration Date: 03/11/2023
• Device Model Number: MP9220-C
• Device Catalogue Number: MP9220-C
• Device Lot Number: 20035960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/17/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other