MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD IV 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	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd iv gravity set was kinked.The following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.The following iv gravity sets have kinks in the line.
Additional Manufacturer Narrative
D4.Medical device lot #: 23085412.D4.Medical device expiration date: 16,aug 2026.H4.Device manufacture date 16, aug 2023.D4.Medical device lot #: 23095054.D4.Medical device expiration date:25,sep 2026.H4.Device manufacture date 25,sep.2023.D4.Medical device lot #: 23095960.D4.Medical device expiration date: 27,sep.2026.H4.Device manufacture date27,sep.2023.D4.Medical device lot #: 23085299.D4.Medical device expiration date: 09,aug.2026.H4.Device manufacture date09,aug 2023.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary pr 10131312: it was reported by customer that iv gravity sets have kinks in the line.Samples for the reported failure mode was requested since to identify any occlusion or flow issues and determine a root cause, however, no samples or pictures were received for evaluation.Device history record model: lot number: lot quantity: qn: q7: mfg: date dyndtn1512 23085299, (b)(4) pcs, none, 200344731: dom & exp date august 11th, 2023, dyndtn1512 23085412, (b)(4) pcs, none, 200344731: dom & exp date september 29th, 2023, dyndtn1512 23095054, (b)(4) pcs, none, 200344731: dom & exp date september 8th, 2023, dyndtn1512 23095960, (b)(4) pcs, none, none, october 04, 2023, qn7: reported during the manufacture of the lot reported is not related to the failure reported.Root cause definition: no root cause definition was determinate due to the customer did not provide a sample for evaluation.Corrective and preventive actions: no preventive and corrective actions required since the failure mode could not be confirmed.We regret any inconveniences caused with our product.We will continue to monitor our customer feedback processes for any similar incidences, implement any corrective actions as appropriate.No related capa/sa/scar has been opened.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.
Event or Problem Description
No additional information was provided.

• Brand Name: BD IV 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: 19392107
• Report Number: 9616066-2024-00793
• Device Sequence Number: 20776437
• Product Code: FPA
• UDI-Device Identifier: 20080196760098
• UDI-Public: (01)20080196760098
• 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): 08/14/2024

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: 08/09/2026
• Device Catalogue Number: DYNDTN1512
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown