MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ADMIN SET MICROBORE TUB 2 MAXZERO CONNEC; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ8002
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a complaint of set missing the blue safety clamp was received from the customer.Seven samples were returned for investigation.Through visual inspection the customer complaint was verfied; all seven samples were assembled without a blue safety clamp.A device history record review for model mz8002 lot number 18075163 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03jul2018.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect is error during the assembly process.
Event or Problem Description
It was reported that 7 admin set microbore tub 2 maxzero connec were missing a tubing clamp before use.The following was reported by the initial reporter: "it was reported that there were 7 packages missing the blue safety slider clamp.Verbatim: tubing missing blue slider clamp.This is a safety clamp that should be present.7 packages missing blue slider clamp".

• Brand Name: ADMIN SET MICROBORE TUB 2 MAXZERO CONNEC
• 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: 11033899
• Report Number: 9616066-2020-20615
• Device Sequence Number: 11079060
• Product Code: FPA
• UDI-Device Identifier: 50885403246911
• UDI-Public: 50885403246911
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: Health Professional
• Device Expiration Date: 07/03/2021
• Device Model Number: MZ8002
• Device Catalogue Number: MZ8002
• Device Lot Number: 18075163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1