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 Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 60 in ultra minibore extension set tubing cracked while being disconnected.The following information was provided by the initial reporter: material #: me2017, batch/ lot #: unknown.It was reported that the end piece of the tubing cracked while being disconnected.Verbatim: rn went to flush and hep lock picc line after abx finished infusing.When disconnecting the tubing, the end piece of the tubing cracked off and remained in the cap of the red lumen of pt's picc.Rn changed cap and saved the cracked tubing and cap.
Event or Problem Description
It was reported that 60 in ultra minibore extension set tubing cracked while being disconnected.The following information was provided by the initial reporter: material #: me2017 batch/ lot #: unknown it was reported that the end piece of the tubing cracked while being disconnected.Verbatim: rn went to flush and hep lock picc line after abx finished infusing.When disconnecting the tubing, the end piece of the tubing cracked off and remained in the cap of the red lumen of pt's picc.Rn changed cap and saved the cracked tubing and cap.
Additional Manufacturer Narrative
Correction device available for eval no.H2: device return to manuf.? :no.Investigation summary no product or photo was returned by the customer.The customer complaint of end piece of tubing could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.Based upon similar complaints received from the customer, it is very likely the male luer was broken.A device history record review could not be performed on model me2017 because a lot number was not provided by the customer.H3 other text : see h.10.

• 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: 10891664
• Report Number: 9616066-2020-20420
• Device Sequence Number: 13810278
• 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,Followup
• Report Date (Section B): 12/09/2020

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 Model Number: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1