MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y MICROBORE EXT W/LUER & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10794983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the y microbore ext w/luer & 2 sld clp experienced component separation.The following information was provided by the initial reporter: material #: 10794983.Batch/ lot #: unknown (possible 20095142) rn was reconnecting the tubing back to the patient.When rn let go, the tubing disconnected from the patient.Looking closer (there was a bifuse at the end of the line) the twisting part of the bifuse was still connected to the patients patient's peripherally inserted central catheter (picc) cap and the rest of the line was not (the twisting part fell off when it's not supposed to).Fortunately, rn caught the line before it fell on the floor and was able to swap out the bifuse for a working one.There was no detectable harm.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of tubing disconnected from the patient could not be verified due to the product not being returned for failure investigation.The actual lot # of the reported device is unknown, but a dhr was done for the potential lot number.A device history record review for model 10794983 lot number 20095142 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample received, an investigation could not be performed and a root cause could not be determined.The actual lot # of the reported device is unknown, but a chc was done for the potential lot #: a complaint history check was performed and there was 1 related complaint previously reported with the defect/condition of separation other component - no leak with lot #20095142 regarding item #10794983.H3 other text : see h.10.
Event or Problem Description
It was reported that the y microbore ext w/luer & 2 sld clp experienced component separation.The following information was provided by the initial reporter: material #: 10794983, batch/ lot #: unknown (possible 20095142).Rn was reconnecting the tubing back to the patient.When rn let go, the tubing disconnected from the patient.Looking closer (there was a bifuse at the end of the line) the twisting part of the bifuse was still connected to the patients patient's peripherally inserted central catheter (picc) cap and the rest of the line was not (the twisting part fell off when it's not supposed to).Fortunately, rn caught the line before it fell on the floor and was able to swap out the bifuse for a working one.There was no detectable harm.

• Brand Name: Y MICROBORE EXT W/LUER & 2 SLD CLP
• 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: 11996772
• Report Number: 9616066-2021-51311
• Device Sequence Number: 19722828
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: 50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/15/2021

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 Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR