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

Catalog Number	10794983
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris extension set was occluded the following information was received by the initial reporter with the following verbatim: when hanging new iv fluid and lines, i was unable to flush the bifuse from either port.I removed the nads and still unable to flush.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
The customer reported that they were unable to flush the line.One sample model 10794983 lot 22119155 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe filled with water and unable to be flushed through either port.Visual inspection under magnification showed signs of excess solvent at the bifuse connector.The customer complaint was verified and a quality notification was sent to the manufacturer.After the investigation at the manufacturing plant, incorrect solvent application by the assembler, and opportunities in the standard work instruction are accepted as possible root causes.A quality alert was created on (b)(6) 2024, to reinforce the correct solvent application method and avoid occlusion.As a corrective action, the standard work instruction was updated.Air fixture will be added in stations where the junction of tubing/bifurcated, approved on (b)(6) 2024.We will continue to monitor our customer feedback process for any similar incidence and implement any corrective action as appropriate.A device history record review for model 10794983 lot number 22119155 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.See h10 below.

• Brand Name: BD ALARIS 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18490003
• Report Number: 9616066-2023-02513
• Device Sequence Number: 6991369
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: (01)50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Catalogue Number: 10794983
• Device Lot Number: 22119155
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown