MAUDE Adverse Event Report: BECTON DICKINSON 8.5 IN PRESSURE RATED SET W/BONDED; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MP5301-C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
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
Material: mp5301-c, batch#: 24089224, 24089191.It was reported by the customer that had 2 iv tubing malfunctions: the first was a pigtail and the second is primary tubing.Both had the end cap disconnect spontaneously:.
Additional Manufacturer Narrative
Is was reported that the male luer separated.One photo was taken by the customer that verifies the complaint.A quality notification was sent to the manufacturer.From the manufacturing investigation, the possible causes of separation could be related to an incorrect solvent application (lack/excess of solvent) by assembler or due to issues with the solvent dispenser or related to an incorrect use of fixtures by the assembler.A quality alert was created on (b)(6) 2025 to communicate the separation complaint and reinforce the correct production process.A dhr review was performed the possible lots reported by customer and no qns related to the failure mode were found.
Event or Problem Description
Material: mp5301-c possible batch#: 24089224, 24089191.It was reported by the customer that had 2 iv tubing malfunctions â¿¿ the first was a pigtail and the second is primary tubing.Both had the end cap disconnect spontaneously: verbatim: rcc received a complaint via email.Email(s) attached.In the past few days, i have had 2 iv tubing malfunctions - the first was a pigtail and the second is primary tubing.Reference # (b)(4) (alaris pump infusion set) - lot # 24095008 - encountered issue (b)(6) 2024 reference # (b)(4) (maxplus pressure rated extension set) - lot # 24089224 or 24089191 - encountered issue over the weekend - (b)(6) 2024.In the past few days i have had 2 iv tubing malfunctions â¿¿ the first was a pigtail and the second is primary tubing.Both had the end cap disconnect spontaneously:.

• Brand Name: 8.5 IN PRESSURE RATED SET W/BONDED
• 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: 20895901
• Report Number: 9616066-2024-02017
• Device Sequence Number: 21066367
• Product Code: FPA
• UDI-Device Identifier: 10885403236600
• UDI-Public: (01)10885403236600(11)240810(17)270810(10)24089224
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: MP5301-C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown