MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D 3SS CV BV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11522558
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2022
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#: 11522558.Batch number#: 22095036.It was reported by customer that issue has been reported regarding potential leaking.Verbatim#: rcc received a complaint via email.Our customer has lodged a complaint regarding item#: 11522558, lot#: 22095036.The complaint is as follows: please note that an issue has been reported regarding potential leaking of l 135161, c # (b)(4) iv set pump w/ball 3 port with lot number (10) 22095036.Value analysis has requested this item and lot number be pulled from use and returned to concordance for return to the manufacturer.Please provide rga for the return of 601 ea of this item.
Additional Manufacturer Narrative
It was reported by customer that issue has been reported regarding potential leaking.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 11522558 lot number 22095036 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01sep2022.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 was provided.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by customer that issue has been reported regarding potential leaking.Three unused samples were received for quality investigation.Visual inspection of the packages and infusion sets were conducted.There were indications of damages or abnormalities on the infusion sets.The infusion sets were then primed with water to determine if there were any issues during priming.No issues were discovered during priming.A simulated infusion was then conducted with the infusion sets with a flow rate of 125 ml/hr for 1 hour per set.There were not issues found during the simulated infusions.The customer complaint of leakage could not be confirmed.A root cause was not established because the reported failure could not be replicated.A device history record review for model 11522558 lot number 22095036 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 01sep2022.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: AS LVP 20D 3SS CV BV
• 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: 19199069
• Report Number: 9616066-2024-00652
• Device Sequence Number: 7620047
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: (01)10885403232305(11)220829(17)250901(10)22095036
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 09/01/2025
• Device Catalogue Number: 11522558
• Device Lot Number: 22095036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 09/23/2024
• Initial Report FDA Received Date: 04/28/2024
• Supplement Report FDA Received Date: 07/15/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown