MAUDE Adverse Event Report: BECTON DICKINSON 36 IN 15 DROP SECONDARY SET W/HGR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MS3500-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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.
Event or Problem Description
Material#: ms3500-15 batch#: unknown it was reported by the customer that rn spiked antibiotic with secondary tubing.Secondary tubing broke/detached at the drip chamber spilling antibiotics on ground.Rn removed tubing from room and obtained a new bag of antibiotics verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no.
Additional Manufacturer Narrative
The customer reported the tubing detached during infusion, and returned one sample of material ms3500-15, lot unknown.Upon initial visual examination, the set verified the complaint of separation.The set was separation at the drip chamber and tubing connection.Under microscope evaluation, insufficient solvent was found on the tubing.A corrective and preventative action was opened by the manufacturing plant to address drip chamber separations on the ms2500-15 set.The action creates support for the solvent dispenser which ensures the correct dimension and alignment of the tube when making the insertion.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
Additional info: this was reported 19-11-2024.

• Brand Name: 36 IN 15 DROP SECONDARY SET W/HGR
• 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: 20877848
• Report Number: 9616066-2024-01937
• Device Sequence Number: 7804806
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/14/2025

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: MS3500-15
• Device Lot Number: UNKNOWN
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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