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

Catalog Number	DYNDTN1545D
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
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 rcc received a complaint via email.Email(s) attached.Blockage, occulsion in the spike date of event: (b)(6) 2024.
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
No additional information was provided.Material #: dyndtn1545 batch#: 23095709 it was reported by customer that blockage, occlusion in the spike.Verbatim: rcc received a complaint via email.Email(s) attached.Blockage, occlusion in the spike date of event: 30jan2024.
Additional Manufacturer Narrative
(b)(4): it was reported by customer that blockage, occlusion in the spike.Sample were received for investigation by dchu vh: sample submitted was tested, however, blocked connection was not confirmed.Based on the photo provided by dchu vh, the tubing has a slight bend, which could cause a possible flow restriction, however, the tubing was massaged out by the investigator by the dchu vh removing the kink, with no further issues.Therefore the failure mode could not be confirmed in tj site for a formal investigation.Root cause definition possible root cause for occlusion could be related to a kink, however this condition could not be determined since the failure mode was not confirmed by the dchu vh/tj site.Corrective and preventive actions no actions were required due the failure mode reported was not confirmed.We regret any inconveniences caused with our product.We will continue to monitor our customer feedback processes for any similar incidences and implement any corrective actions as appropriate.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 18769359
• Report Number: 9616066-2024-00287
• Device Sequence Number: 7646130
• Product Code: FPA
• UDI-Device Identifier: 40080196714934
• UDI-Public: (01)40080196714934
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: DYNDTN1545D
• Device Lot Number: 23095709
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown