MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP SS BAG 20D LOW SORB SS 0.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number	2465-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: 2209524 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.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 while using (brand name) components separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we have had recent incidents of bag spikes (administration sets for bd alaris pumps) falling out of the iv port and exposing nurses to drug residue.Nurses were splashed with drug residue upon different incidents of drug administration.Examples was nursing flushing the line and hanging bags for administration.Its seems the ports are not forming a secure hold with the iv administration sets.¿ was there any medical intervention needed? no, occupational medicine consulted, rn instructed to wash impacted area with soap and water and change scrubs.
Additional Manufacturer Narrative
Investigation summary no photo or sample was received for the customer's complaint of separation leak.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported while using bd alaris¿ lvp ss bag 20d low sorb ss 0.2m components separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we have had recent incidents of bag spikes (administration sets for bd alaris pumps) falling out of the iv port and exposing nurses to drug residue.Nurses were splashed with drug residue upon different incidents of drug administration.Examples was nursing flushing the line and hanging bags for administration.Its seems the ports are not forming a secure hold with the iv administration sets.¿ ¿ was there any medical intervention needed? no, occupational medicine consulted, rn instructed to wash impacted area with soap and water and change scrubs.

• Brand Name: BD ALARIS¿ LVP SS BAG 20D LOW SORB SS 0.2M
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16118075
• Report Number: 9616066-2022-02157
• Device Sequence Number: 12502922
• Product Code: FPA
• UDI-Device Identifier: 50885403221949
• UDI-Public: (01)50885403221949
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 01/29/2023

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: 2465-0007
• Device Catalogue Number: 2465-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/29/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown