MAUDE Adverse Event Report: BECTON DICKINSON 32" GRAV SET W/0.2 MICRON FILTER TEXIUM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	4030B-07T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 4030b-07t.Batch # 23039083.It was reported by customer that tubing attached to distal end of filter fell off - noted during priming the line with nacl 0.9%.Verbatim: rcc received a complaint via community.Could have been a spill even if this happened while the beleodaq was infusing into the patient or even if it spilled inside of hood.Potential risks to pharmacy tech,pharmacist, nursing, patient, andpatient visitor.Tubing attached to distal end of filter felloff - noted during priming the line withnacl 0.9%.
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
No additional info.
Additional Manufacturer Narrative
It was reported that the tubing separated from the filter.One sample model 4030b-07t, lot 23039083 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the filter outlet port.No other defects or abnormalities were observed.The customer complaint is verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the potential root cause for separation between tubing sleeve and filter could be related to lack of solvent due to using an incorrect solvent application method by the assembler.A quality alert was created on february 22nd, 2024 to reinforce the correct solvent application method and avoid the lack of solvent.A device history record review for model 4030b-07t lot number 23039083 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15 mar 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: 32" GRAV SET W/0.2 MICRON FILTER TEXIUM
• 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: 19983309
• Report Number: 9616066-2024-01131
• Device Sequence Number: 8082886
• Product Code: FPA
• UDI-Device Identifier: 10885403240867
• UDI-Public: (01)10885403240867(11)230302(17)260315(10)23039083
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/30/2024

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: 03/15/2026
• Device Catalogue Number: 4030B-07T
• Device Lot Number: 23039083
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown