MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 36 IN NON-DEHP MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the 36 in non-dehp minibore extension set cracked at the hub.The following information was provided by the initial reporter: "several staff members are reporting that the extension set is cracking at the hub.The latest issue was with lot # 20045106.".
Additional Manufacturer Narrative
H.6.Investigation: a complaint of sets cracking at the hub was received from the customer.1188 samples were received for investigation.Evaluation of 59 samples were performed.The sample size quantity was determined per procedure.The seal of the hub did look slightly more pronounced on some of the samples, but no defects were found.The customer's complaint could not be verified.A device history record review for model me1110 lot number 20045106 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with lot #20045106 regarding item #me1110.A root cause could not be determined due to the complaint not being able to be verified.See h.10.
Event or Problem Description
It was reported that the 36 in non-dehp minibore extension set cracked at the hub.The following information was provided by the initial reporter: "several staff members are reporting that the extension set is cracking at the hub.The latest issue was with lot # 20045106.".

• Brand Name: 36 IN NON-DEHP MINIBORE EXTENSION 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: 10766677
• Report Number: 9616066-2020-20218
• Device Sequence Number: 16428829
• Product Code: FPA
• UDI-Device Identifier: 50885403236042
• UDI-Public: 50885403236042
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/23/2020

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: 04/02/2025
• Device Model Number: ME1110
• Device Catalogue Number: ME1110
• Device Lot Number: 20045106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1