MAUDE Adverse Event Report: BECTON DICKINSON BAG ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2300E-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Materials: 2300e-0500.Batch#: 24025033.It was reported by the customer that "cracked luer lock".Verbatim: rcc received a complaint via email.Email(s) attached.Chc complaint reference #: (b)(4).Hospital complaint reference #: (b)(4).(b)(6).Correspondence language: english.Cat# of product being complained: al2300e-0500.Description of product: bag access device (b)(4).Lot or s/n: (b)(6).Complaint category: damaged / broken.Reportable: no.Incident date: (b)(6) 2024.Hospital complaint reference #: (b)(4).Details of complaint (reported issue): "cracked luer lock".Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.Has health canada been informed? unknown.Qty affected: 2 ea.Samples available? no.Is customer requesting an rga? no.
Additional Manufacturer Narrative
It was reported that the sample cracked.Two photos were taken by the customer that confirm the complaint and a quality notification was sent to the manufacturer.From the manufacturer's investigation, it was not possible to determine the most possible root cause that generates the condition reported due we were not able to replicate the failure in the current process.Lot reported was manufactured on feb 07th, 2024, before actions for improvements in the preventive maintenance for the fixture.Following actions were defined: the fixture spike press procedure was updated to specify that preventive maintenance is required for this fixture to ensure that the equipment is in optimal conditions for use.Completed on jul 31st, 2024.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Materials: 2300e-0500 batch#: 24025033.It was reported by the customer that "cracked luer lock." rcc received a complaint via email.Chc complaint reference #:(b)(4), hospital complaint reference #: (b)(4), customer (hospital) name: xx xxxx xxxx - xxxxx xxxx, customer address: xxx xxx xxx x xxxxxx - xxx xxxx, xxxx, xx, xxxx, (b)(6), contact name: xxx xx xx, phone: xxxxxxxxxx(ext: xxx), e-mail: xxxx.Xxx@xxxx.Xx.Xx.Correspondence language: english, cat# of product being complained: (b)(4), description of product: bag access device 100ea/ca, lot or s/n: (b)(6), complaint category: damaged / broken, reportable: no, incident date: (b)(6) 2024, hospital complaint reference #:(b)(4), details of complaint (reported issue): "cracked luer lock," complaint noticed: during / after use, problem frequency: 1st time.Customer exposure: patient injury: no has health canada been informed? unknown qty affected: 2 ea samples available? no is customer requesting an rga?: no return qty:.

• Brand Name: BAG ACCESS DEVICE
• 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: 20798126
• Report Number: 9616066-2024-01750
• Device Sequence Number: 7980636
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: (01)10885403235023(11)240201(17)270201(10)24025033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 2300E-0500
• Device Lot Number: 24025033
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown