MAUDE Adverse Event Report: BECTON DICKINSON SEC SET NO PORTS W/HANGER DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11448964
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 630-02194.Lot#: 23073035.It was reported by the customer reported "spiked mini bag with magnesium in it and secondary set bag spike broke in bag and magnesium leaked out on to nurse.The physical set in the cancer care space will also make clear the issue." verbatim: "spiked mini bag with magnesium in it and secondary set bag spike broke in bag and magnesium leaked out on to nurse.The physical set in the cancer care space will also make clear the issue.".
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information was provided.Material#: 11448964, lot#: 23073035.It was reported by the customer reported "spiked mini bag with magnesium in it and secondary set bag spike broke in bag and magnesium leaked out on to nurse.The physical set in the cancer care space will also make clear the issue." verbatim: "spiked mini bag with magnesium in it and secondary set bag spike broke in bag and magnesium leaked out on to nurse.The physical set in the cancer care space will also make clear the issue.".
Additional Manufacturer Narrative
It was reported by the customer reported "spiked mini bag with magnesium in it and secondary set bag spike broke in bag and magnesium leaked out on to nurse." two photos were received of material 11448964 for quality evaluation.One photo is of the product packaging and one photo shows the indicated failure.Review of the photo of the failure shows that the spike of the drip chamber broke off.Based on the appearance of the spike and the location of the break, along with the description of the failure provided by the customer, the probable root cause for the failure is a user issue.If the spike of the drip chamber is not inserted into an infusion bag, and not straight into the bag port, excess force along with the attempting to insert the spike at an angle to the port can cause the spike to break.A device history record review for model 11448964, lot number 23073035 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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: SEC SET NO PORTS W/HANGER DEHP FREE
• 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 IL 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18608517
• Report Number: 9610847-2024-00015
• Device Sequence Number: 2722878
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• 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): 04/10/2024

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 Expiration Date: 07/30/2026
• Device Catalogue Number: 11448964
• Device Lot Number: 23073035
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown