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

Catalog Number	DYNDTN1512
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd gravity set was occluded.The following information was received by the initial reporter with the following verbatim.¿tubing sealed at the opening and fluid is unable to go through the tubing.¿.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that tubing sealed at the opening and fluid is unable to go through the tubing.Two samples received for quality investigation.Visual inspection of the samples show a kink just below the drip chamber.Further examination under magnification indicates that the tubing looks to be held together by bonding solvent.The infusion sets where then tested to see if fluid would move past the kink in the tubing.No fluid flow was allowed past the kinks.The customer complaint of tubing defective / damaged was confirmed.An investigation for the root cause was forwarded to manufacturing for root cause analysis.After investigation, leakage due to tear in the silicone tubing reported by the customer could not be replicated in the production process and no opportunities were found in the manufacturing of the model and affected subassembly, due to this, the failure mode was not found to be related to the tijuana manufacturing process.Based on previous issues of the similar type, the probable cause for the tearing in the silicone tubing is a misloading of the infusion set into the alaris pump.If the set is not loaded correctly, holes or tears can develop very easily.No corrective or preventive actions were determined for this complaint since the root cause could not be determined.Although, we will continue to track and trend and if any negative trend is observed, proper actions will be deemed necessary.A device history record review for model dyndtn1512 lot number 24075141 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.No corrective or preventive actions were determined for this complaint since the root cause could not be determined.Although, we will continue to track and trend and if any negative trend is observed, proper actions will be deemed necessary.
Event or Problem Description
No additional information was provided.

• Brand Name: BD 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: 21735744
• Report Number: 9616066-2025-00705
• Device Sequence Number: 9002354
• Product Code: FPA
• UDI-Device Identifier: 20080196760098
• UDI-Public: (01)20080196760098(11)240726(17)270726(10)24075141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 06/27/2025

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: DYNDTN1512
• Device Lot Number: 24075141
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown