MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8.5 IN PRESSURE RATED MINIBORE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MP5302-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: a complaint of damaged tubing was received from the customer.No product or photo was returned by the customer.The customer complaint of damaged tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mp5302-c because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that 8.5 in pressure rated minibore set tubing split open and leaked.The following information was provided by the initial reporter: material no: unknown, mp5302-c, batch no: unknown it was reported that there was a safety event where the ed used this tubing and tried to inject contrast for the ct, but the tubing split open and contrast leaked all over the patient.
Event or Problem Description
It was reported that 8.5 in pressure rated minibore set tubing split open and leaked.The following information was provided by the initial reporter: material no: unknown, mp5302-c batch no: unknown it was reported that there was a safety event where the ed used this tubing and tried to inject contrast for the ct, but the tubing split open and contrast leaked all over the patient.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of damaged tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mp5302-c because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.

• Brand Name: 8.5 IN PRESSURE RATED MINIBORE 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: 10722897
• Report Number: 9616066-2020-20176
• Device Sequence Number: 1902321
• Product Code: FPA
• UDI-Device Identifier: 50885403230132
• UDI-Public: 50885403230132
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/30/2020

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 Model Number: MP5302-C
• Device Catalogue Number: MP5302-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/22/2020
• 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
• Patient Age: 2 DA