MAUDE Adverse Event Report: BECTON DICKINSON 7 INCH MIC EXT SET W/1.2MF; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20129E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material #: 20129e.Batch #: unknown.It was reported by the customer that have found that the amber tubing does not consistently seat properly with the lipid filters.Verbatim: rcc received a complaint via email.Email(s) attached.Patient - 1( (b)(4) ).Bd extension set amber tubing, ref (b)(4), lot: (10)24049060.Nicu has put the amber tubing into place to light protect intralipids, smof, omegaven, as well as secondary tpn syringes.We have found that the amber tubing does not consistently seat properly with the lipid filters (bd (b)(4) ).This has been found on 4 patients.The ends of the lipid filters seem to have a different color plastic and make a friction noise when connected.This has only been found with the 1.2 micron filter not the 0.2 micron filter (used for tpn).Due to the increased risk of infection and suboptimal nutrition we have pulled the product.Please let us know if you are aware of this problem at any other institution(s).
Additional Manufacturer Narrative
Investigation results: it was reported that the set would not connect properly to the filter tubing.Two samples model 20129e, lot 241049319 from (b)(4) were returned for investigation along with two samples model 10241342, lot 24049060 from (b)(4).The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The 10241342 sets were connected to the 20129e extension sets.The sets were flushed with water.No leak was observed.An air under water pressure test was performed at around 10 psi.No leak was observed from the connection of the two sets.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20129e lot number 24049319 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19apr2024.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: 7 INCH MIC EXT SET W/1.2MF
• 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: 19851858
• Report Number: 9616066-2024-01057
• Device Sequence Number: 15042960
• Product Code: FPA
• UDI-Device Identifier: 10885403234903
• UDI-Public: (01)10885403234903(11)240419(17)270419(10)24049319
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 10/21/2024

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: 20129E
• Device Lot Number: 24049319
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown