MAUDE Adverse Event Report: BECTON DICKINSON EXT SET SMALLBORE TBG W/SS DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10011253
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr with device evaluation.No product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material# 10011253 and lot# 24089267 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13aug2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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.
Event or Problem Description
Material # 10011253; batch # unknown.It was reported by customer that they keep getting an occlusions error when using with our bracco rb 82 generator and medrad intego radiopharmaceutical dosing system on just about every patient.Verbatim: hi, nuclear medicine is experiencing issues with the new bd smart site extension se (ref 10011253), we keep getting an occlusions error when using with our bracco rb 82 generator and medrad intego radiopharmaceutical dosing system on just about every patient.Resulting in having to replace and hops that the replacement works.

• Brand Name: EXT SET SMALLBORE TBG W/SS 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: 20798176
• Report Number: 9616066-2024-01748
• Device Sequence Number: 7894515
• Product Code: FPA
• UDI-Device Identifier: 10885403233609
• UDI-Public: (01)10885403233609(11)240813(17)270813(10)24089267
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 11/01/2024

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 Catalogue Number: 10011253
• Device Lot Number: 24089267
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown