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

Catalog Number	MFS132
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that when administering meds through the bd gravity administration set it no longer dripped.The following information was provided by the initial reporter: material#: mfs132, batch#: 22099219.It was reported by the customer that the tubing was defected.When did this occur? it appears that when we were restocked, this particular batch was defective.What is the product# ? mfs132 lot number: 22099219.Can you advise any additional details that occurred? after administering meds through the y-sites the tubing no longer drips, resulting in us having to change out the entire set.Were there any adverse events? no, each time the actual iv was patent with blood return.Is the tubing available for return or do you have a photo? we discarded the defective tubing.
Event or Problem Description
It was reported by the customer that when administering meds through the bd gravity administration set it no longer dripped.The following information was provided by the initial reporter: material #: mfs132, batch #:22099219.It was reported by the customer that the tubing was defected.Verbatim: mds-isd verbatim: when did this occur? it appears that when we were restocked, this particular batch was defective.What is the product #? mfs132 lot number 22099219.Can you advise any additional details that occurred? after administering meds through the y-sites the tubing no longer drips, resulting in us having to change out the entire set.Were there any adverse events? no, each time the actual iv was patent with blood return.Is the tubing available for return or do you have a photo? we discarded the defective tubing.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.It was reported by the customer that the tubing was defected could not be verified due to the product not being returned for failure investigation.A device history record review for model mfs132 and lot number 22099219 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received a root cause could not be determined.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 ADMINISTRATION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15749262
• Report Number: 9616066-2022-01688
• Device Sequence Number: 15033193
• Product Code: FPA
• UDI-Device Identifier: 10885403236419
• UDI-Public: 10885403236419
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 09/09/2025
• Device Catalogue Number: MFS132
• Device Lot Number: 22099219
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown