MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD AS LVP 10D 3SS 2G-4WSPK CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015896
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 18oct2022.Medwatch report # mw5112770.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 bd as lvp 10d 3ss 2g-4wspk cv the connection was damaged.There was no report of patient impact.The following information was provided by the initial reporter: connection site was misshaped, would not properly fit into iv site properly.Iv tubing changed.
Additional Manufacturer Narrative
H6: investigation summary a complaint of a set not being able to be connected due to a misshaped component was received.No product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for model 10015896 lot number 22065630 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 08jun2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported while using bd as lvp 10d 3ss 2g-4wspk cv the connection was damaged.There was no report of patient impact.The following information was provided by the initial reporter: connection site was misshaped, would not properly fit into iv site properly.Iv tubing changed.

• Brand Name: BD AS LVP 10D 3SS 2G-4WSPK CV
• 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: 15824024
• Report Number: 9616066-2022-01772
• Device Sequence Number: 20360766
• Product Code: FPA
• UDI-Device Identifier: 50885403234062
• UDI-Public: 50885403234062
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 11/18/2022

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 Expiration Date: 06/08/2025
• Device Model Number: 10015896
• Device Catalogue Number: 10015896
• Device Lot Number: 22065630
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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