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

Catalog Number	10387509
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
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 gravity blood set was missing a component the following information was received by the initial reporter with the following verbatim.It was reported by customer that platelet tubing missing the roller clamp.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported the roller clamp was missing and returned one unused sample of material 10387509, batch 23029304.Visual inspection of the set verified the complaint.The manufacturing plant found the root cause for the missing roller clamp to be related to the assembly sequence.A retraining was carried out on 04sep2024 with involved personnel to ensure correct assembly procedure of the roller clamp, and the work instruction was also enforced.Device history record review for model 10387509 lot number 23029304 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27feb2023.There was a quality notification issued for the same failure mode, model, and specific area, #200387832.The qn found the possible rot cause was not following the assembly sequence correctly.Additionally, on 21sep2023, opportunities in the fixture 2107 were found and a work order was performed to address the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS GRAVITY BLOOD 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: 20517846
• Report Number: 9616066-2024-01534
• Device Sequence Number: 15402188
• Product Code: FPA
• UDI-Device Identifier: 10885403234217
• UDI-Public: (01)10885403234217(11)230220(17)260227(10)23029304
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 11/07/2024

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: 02/27/2026
• Device Catalogue Number: 10387509
• Device Lot Number: 23029304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown