MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D DEHP 2SS CV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2420-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 2420-0500, batch#: 24073309.It was reported by the customer that was transported to di via stretcher with iv pump running 2 channels to dual lumen picc.One iv line (ns medline) running between iv pump and pt's picc line was found with a perforation (line appeared to be partially severed/ripped) by rn.Nurse reported that blood was backflowing from pt picc line up through iv line and actively dripping out of the perforation onto the floor and iv pole.She reported that she disconnected the broken iv line and clamped the picc lumen closed as found.Pt was assessed on return to unit, vitals unchanged from am assessment.Picc line flushed and functional.Defect in iv line assessed and photo of iv line taken.Rcc received a complaint via email.Pt was transported to di via stretcher with iv pump running 2 channels to dual lumen picc.One iv line (ns medline) running between iv pump and pt's picc line was found with a perforation (line appeared to be partially severed/ripped) by rn.Nurse reported that blood was backflowing from pt picc line up through iv line and actively dripping out of the perforation onto the floor and iv pole.She reported that she disconnected the broken iv line and clamped the picc lumen closed as found.Pt was assessed on return to unit, vitals unchanged from am assessment.Picc line flushed and functional.Defect in iv line assessed and photo of iv line taken.Hg to be repeated in afternoon.Manufacturer code/model: 2420-0500.Serial or lot number: (b)(6).
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
Investigation results: it was reported that the tubing was leaking.One sample model 2420-0500, lot 24073309 was returned for investigation.The set was examined for defects and abnormalities.There was a hole in the tubing.No other defects or abnormalities were observed.The customer complaint was verified.Based on the damage not being found until after the infusion started it is not likely that this is a manufacturing issue.The most probable cause is that the tubing got caught on something and tore.A device history record review for model 2420-0500 lot number 24073309 was performed.The search showed that a total of (b)(4).Units in 1 lot number was built on 23jul2024.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.
Event or Problem Description
No additional information.

• Brand Name: AS LVP 20D DEHP 2SS CV
• 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: 20819952
• Report Number: 9616066-2024-01780
• Device Sequence Number: 15374373
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430(11)240723(17)270723(10)24073309
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• 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: 2420-0500
• Device Lot Number: 24073309
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown