MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60 IN ULTRA MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2017
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: one sample was received for quality investigation.The customer complaint of the tubing cracked at the connection site was verified by visual inspection.Microscopic evaluation of the connection site was conducted and it can clearly be see that the tubing from the male luer cracked inside the connection for the patients piv tubing provided by the customer.Further examination shows damage to the luer body.Multiple cracks can bee seen through the luer body.A device history record review could not be performed on model me2017 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 for the cracking and breakage seen on the sample can be due to over torquing of the luer.Due to the luer not showing any signs of leakage or cracks prior to its use, and the connection cracking at the time the rn was disconnecting the tubing, along with the type of cracks and breakage seen on the sample, the root cause was determined to be excessive force used to disconnect the tubing.
Event or Problem Description
It was reported that 60 in ultra minibore extension set tubing cracked.The following information was provided by the initial reporter: material #: me2017, batch/ lot #: unknown.It was reported that when the tubing was disconnected from the patients picc line, the tubing cracked at the connection site.Verbatim: iv tubing broke off in the port of patient's piv.Nurse was able to save piv.Medline tubing connected to patient without issue or concern by this rn.Medication infusion completed, this rn disconnected medline tubing from patient's picc line and the tubing cracked at the site that connects to the needleless hub.The portion that cracked remained lodged in the picc cap hub.Pressure maintained keeping the line open.Line was clamped and hub wrapped with alcohol swab.Caused cap on line to need changing increasing additional exposure.Iv tubing and picc cap hub saved.

• Brand Name: 60 IN ULTRA 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: 10892074
• Report Number: 9616066-2020-20427
• Device Sequence Number: 11120082
• Product Code: FPA
• UDI-Device Identifier: 50885403236240
• UDI-Public: 50885403236240
• 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
• Report Date (Section B): 11/11/2020

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: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1