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

Catalog Number	MP5313-C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the customer reported leakage at the connection to the catheter and returned one used sample, and a maxzero.The sample was primed with blue dye fluid from a syringe, and there was no observed leak.The maxzero was placed on both the female and male luer of the set and neither had a leak, and the complaint cannot be verified.The customer reported the lot number as "unknown" but provided two possible lot numbers.A device history record review for model mp5313-c lot number 21015872 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mp5313-c lot number 20106030 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Root cause description: the root cause is unknown without an observed failure.
Event or Problem Description
It was reported that 8.5 in pressure rated minibore set leaked.The following information was provided by the initial reporter: it was reported by the customer that the extension set is leaking at the connection to catheter.

• 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
• MDR Report Key: 12194161
• Report Number: 9616066-2021-51557
• Device Sequence Number: 1494214
• Product Code: FPA
• UDI-Device Identifier: 10885403236716
• UDI-Public: 10885403236716
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2021

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 Catalogue Number: MP5313-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1