MAUDE Adverse Event Report: BECTON DICKINSON EXT SET 1.2MF 1SS DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20127E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: 20127e.Batch number#: 23049266.It was reported by customer that lipid filter reading occluded after all intervention.Verbatim#: rcc received a complaint via phone.Pir attached.Lipid filter reading occluded after all intervention.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Investigation and dhr the customer reported the filter was occluded and returned one used sample of material 20127e and lot 23049266.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water.An infusion run was started at a rate of 1 ml/hr for 24 hrs.No observation on occlusion was observed.The customer complaint was unable to be replicated.Although the issue was unable to be replicated and the root cause is unknown, bd is looking at opportunities to improve the filter function to alleviate this failure in the future.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Device history record review for model 20127e lot number 23049266 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25apr2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: EXT SET 1.2MF 1SS DEHP FREE
• 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: 18607713
• Report Number: 9616066-2024-00122
• Device Sequence Number: 9078073
• Product Code: FPA
• UDI-Device Identifier: 07613203019248
• UDI-Public: (01)07613203019248
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 05/01/2024

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: 04/20/2026
• Device Catalogue Number: 20127E
• Device Lot Number: 23049266
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown