MAUDE Adverse Event Report: BECTON DICKINSON AS LVP BLD200M 20D DEHP SMBORE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2278-0500
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission with device evaluation.No product or photo was returned by the customer.The customer complaint of flow issues - back flow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2278-0500 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
Material: unknown batch#: unknown it was reported by the customer that rn was able to remove the spike and spiked the normal saline flush.The blood backflowed from the tubing up into the normal saline bag causing the entire flush to go pink in colour and diluted with blood.Verbatim: rcc received a complaint via email.Email(s) attached.Rn was able to remove the spike and spiked the normal saline flush.The blood backflowed from the tubing up into the normal saline bag causing the entire flush to go pink in colour and diluted with blood.

• Brand Name: AS LVP BLD200M 20D DEHP SMBORE
• 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: 19940461
• Report Number: 9616066-2024-01111
• Device Sequence Number: 7432651
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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: 2278-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/08/2024
• 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