MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10012143
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd smart site extension set was damaged.The following information was received by the initial reporter with the verbatim: describe the event or problem: adult female gestitional age 40w6d receiving pitocin during l&d; rn noticed bedding was soaking and noted pitocin draining from hub on y connector as it was cracked.Pt had prolonged second stage, vac assist w/3 pop-offs and potential c/s but baby delivered vaginally from roa position.Mom & baby tolerated delivery well, no complications.
Additional Manufacturer Narrative
E4.The initial reporter also notified the fda on aug, 2023.Medwatch report # (b)(4).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Sample inv and dhr: the customer reported a cracked hub and returned one used sample.The sample was cracked at one of the two female luers, and the complaint is verified.The root cause for this issue has been seen with alcohol on the luers causing them to lose structural integrity.Device history record review for model 10012143 lot number 22079373 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SMARTSITE 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17808048
• Report Number: 9616066-2023-01936
• Device Sequence Number: 17815458
• Product Code: FPA
• UDI-Device Identifier: 50885403233669
• UDI-Public: (01)50885403233669
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/07/2024

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: 07/20/2025
• Device Catalogue Number: 10012143
• Device Lot Number: 22079373
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White