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

Catalog Number	42511E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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 the bd alaris smartsite gravity set had flow issues.The following information was provided by the initial reporter: can't draw back from 2 of the ports.
Additional Manufacturer Narrative
Two of the samples showed evidence that the luer connection between the stopcocks of the assembly were cracked.The customer complaint of connection issues was confirmed.The third sample submitted shows that the tubing after the male luer directly after the two stopcock connections is missing.The customer claim of misassembly was confirmed.The fourth sample shows that the distal male luer connection is missing from the assembly.Further examination under magnification shows that there is no evidence of solvent on the bonding surfaces.The customer complaint of separation was confirmed.Due to the condition of the samples provided, none of the sample could be tested for flow issues.Each of the samples were damaged and flow testing could not be conducted.Investigation of root cause was forwarded to manufacturing for evaluation.A root cause analysis for flow issues could not be conducted because the samples submitted could not be investigated due to the damages on the samples.The damage to the stopcock connectors could not be replicated at the manufacturing facility in the production process.Additionally, there were no indications that the issue could have been created during the handling of the product during production.Review of the customer description of events indicate that the issue was detected during use and therefore a root cause for the failure could not be determined.The investigation to the separated tubing and the missing second section of the tubing indicated that the root cause for the issue was that the assembler did not follow the work instructions correctly at the manufacturing facility.This product has been moved to a different manufacturing facility and we will continue to track and trend if any negative trend is observed.A device history record review for model 42511e lot number 25019227 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Additional Manufacturer Narrative
Follow up for corrected device evaluation.One sample of product 42511e was submitted for quality evaluation.Four samples of product mx4452 were also received and will be addressed in bd complaint (b)(4).Examination of the sample of 42511e indicates that it is missing the rest of the tubing after the male luer connector after two t-connectors.The customer complaint of misassembly was confirmed.Due to the sample not having the rest of the tubing, the reported failures of flow issues - fluid blockage, connection issues, flow issues - accuracy and separation could not be confirmed.The investigation of the missing second section of the tubing indicated that the root cause for the issue was that the assembler did not follow the work instructions correctly at the manufacturing facility.This product has been moved to a different manufacturing facility and we will continue to track and trend if any negative trend is observed.A device history record review for model 42511e lot number 25019227 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 22755331
• Report Number: 9616066-2025-02295
• Device Sequence Number: 21219306
• Product Code: FPA
• UDI-Device Identifier: 10885403235412
• UDI-Public: (01)10885403235412
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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: 42511E
• Device Lot Number: 25019227
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/16/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/02/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown