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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 21016366.Medical device expiration date: 2024-01-19.Device manufacture date: 2021-01-19.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that ext w/ss rem spin luer & 1 sld clp had flow issues.This occurred on 5 occasions.The following information was provided by the initial reporter: event #: 1 material #: 22059e, batch/lot #: unknown.Event #: 2 material #: 22059e, batch/lot #: 21016366.It was reported that the needle-free valve on the extension would not open.Verbatim: this weekend i had a couple of nurses call me from the ed.They said that the needle-free valve on these extensions would not open on about 30% of the product.When inquired that maybe we received a bad case they said they have been having this issue for several weeks.
Additional Manufacturer Narrative
H6: investigation summary four samples (model # 22059e) were returned by the customer.It was reported that the needle-free valve on the extension would not open.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then flushed with water to confirm an open fluid path.The fluid paths of all four samples were open and those samples were able to be flushed.The failure was unable to be replicated, and the complaint could not be verified.A device history record review for model 22059e lot number 21016366 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was unable to be determined.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.H3 other text : see h10.
Event or Problem Description
It was reported that ext w/ss rem spin luer & 1 sld clp had flow issues.This occurred on 5 occasions.The following information was provided by the initial reporter: event #: 1 material #: 22059e batch/lot #: unknown event #: material #: 22059e batch/lot #: 21016366 it was reported that the needle-free valve on the extension would not open.Verbatim: this weekend i had a couple of nurses call me from the ed.They said that the needle-free valve on these extensions would not open on about 30% of the product.When inquired that maybe we received a bad case they said they have been having this issue for several weeks.

• 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: 11721090
• Report Number: 9616066-2021-50809
• Device Sequence Number: 17150324
• 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): 05/04/2021

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: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1