MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located, and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the unspecified bd infusion set had leakage.The following information was provided by the initial reporter: leaking between the 2 stopcocks where it is bonded.Additional information received from the customer: will you confirm if the material or batch number is known for these events? i cannot confirm a lot #.The tubing was already in use and packaging had already been disposed of early in the day.Describe if any patient harm, injury, complication or negative outcome occurred as a result of each event.Leaking between the stopcocks at the bonded site-potential increased risk of infection.
Additional Manufacturer Narrative
Two photos were submitted for quality evaluation.One photo shows that the roller clamp appears to be upside down.The second photo shows two stopcocks connected together, however, it does not depict that the stopcock was leaking.The customer complaint of misassembly was confirmed, but the customer complaint of leakage could not be verified.Due to the physical sample not being available, the root cause for the misassembly failure could not be determined.Additionally, since the physical samples were not received the leakage between the stopcocks could not be confirmed and a root cause was not determined.
Event or Problem Description
No additional information provided.

• Brand Name: UNSPECIFIED BD INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22766717
• Report Number: 2243072-2025-00965
• Device Sequence Number: 8152974
• Product Code: FPA
• UDI-Device Identifier: 10885403235412
• UDI-Public: (01)10885403235412
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/09/2025
• Supplement Report FDA Received Date: 10/07/2025
• 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