MAUDE Adverse Event Report: BECTON DICKINSON V BURETTE 30IN SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	82105EH
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Rn stated that when administering fluids using alaris system and a burette set up, that the content isn't emptying completely.For example, 100mls of volume running at 100mls/hr, the fluid in the burette after one hour leaves around 10-15mls (instead of being completed) and the nurse has to come back to ensure the remainder of the fluid has gone through.The nurse states, this is time consuming, results in unwanted nuisance alarms and can be high risk with critical drugs.(b)(6) has notified, (b)(4) who is clinical products for the department, and notified the num of icu.This occurrence has happened on multiple occasions.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Follow up mdr for device evaluation.No samples were received for investigation of pr (b)(4), in which the customer has stated that, "when administering fluids using alaris system and a burette set up, that the content isn't emptying completely." this feedback is in reference to 82105eh products.The lot number was not available.No additional information was available to assist the investigation in this instance.The details of this feedback were forwarded to the legal manufacturer of the product, anhui tiankang medical products co.Ltd, for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 82105eh set over the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: V BURETTE 30IN SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20878110
• Report Number: 9616066-2024-01941
• Device Sequence Number: 15404997
• Product Code: FPA
• UDI-Device Identifier: 07613203009638
• UDI-Public: (01)07613203009638
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: Health Professional
• Device Catalogue Number: 82105EH
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/09/2024
• 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