MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT W/SS REM SPIN LUER & 1 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	22059E
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that ext w/ss rem spin luer & 1 sld clp was damaged.The following information was provided by the initial reporter: material #: 22059e.Batch/lot #: unknown.It was reported that the device blew out.
Additional Manufacturer Narrative
H6: investigation summary: one sample was received for quality investigation.The customer complaint of component damage was verified by visual inspection.The sample received was seen to have a large tear in the tubing parallel to the longitudinal axis of the tubing.Further testing on the sample could not be conducted because of the damage to the tubing of the sample submitted.A device history record review could not be performed on model 22059e because a lot number was not provided by the customer.The investigation was not able to find a definitive root cause for the product failure.The probably root cause for the issue seen in this complaint is that the tubing burst when the customer attempted to flush the extension set when they noticed that blood was backing up into the the extension set.The backup of blood into the line and the increase in pressure in the tubing due to the customer attempting to flush the line, caused the tubing to burst.H3 other text : see h10.
Event or Problem Description
It was reported that ext w/ss rem spin luer & 1 sld clp was damaged.The following information was provided by the initial reporter: material #: 22059e batch/lot #: unknown.It was reported that the device blew out.

• Brand Name: EXT W/SS REM SPIN LUER & 1 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: 11860788
• Report Number: 9616066-2021-51081
• Device Sequence Number: 4413925
• Product Code: FPA
• UDI-Device Identifier: 10885403235016
• UDI-Public: 10885403235016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 06/10/2021

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 Catalogue Number: 22059E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1