MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD EXT SET 15CM SMALL BORE SPIN NUT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385151
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd ext set 15cm small bore spin nut leaked the following information was provided by the initial reporter; dear partner, i am sending new complaint form for product with ref:(b)(4).The complaint was filed by the (b)(6) hospital again as they don't agree with closure of complaint investigation report :number: (b)(4).Would you be so kind and notice us how to proceed.The hospital pharmacy has received multiple complaints regarding product 385151 (q-syte ext.Set micro 6" a50) with the explanation that they have detected leakage at the point where the tube of the ext.Set connects to the luer lock connector made of a harder plastic (on the iv cannula site).When injected with slightly greater force or speed, and/or if the infusion continued for an extended period, a droplet of liquid appeared at the point between the tube and the plastic luer lock connector.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 opened and used samples as well as 50 unopened samples submitted for evaluation.The reported issue of leakage was confirmed upon inspection and testing of the samples.Analysis of the samples showed that one of the used samples experienced leakage at the union site of the tubing and fitting luer.This sample had no additional devices connected to it.The other used sample had a grey catheter attached to it, but the sample passed the leakage testing with no failure observed.All the 50 unopened samples passed the leakage testing as well.Bd determined that the cause of the failure is possibly related to our supplier¿s process.Our supplier performed an investigation and confirmed the failure was a result of their process.There was a small pinhole on the affected sample when viewed under a microscope.It is believed that the hole was formed by the use of excessive bonding solvent, which caused corrosion and damage to the tubing.Our supplier has decided to increase the sample size of their air leakage testing and to perform additional training with their manufacturing personnel on the observed failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 opened and used samples as well as 50 unopened samples submitted for evaluation.The reported issue of leakage was confirmed upon inspection and testing of the samples.Analysis of the samples showed that one of the used samples experienced leakage at the union site of the tubing and fitting luer.This sample had no additional devices connected to it.The other used sample had a grey catheter attached to it, but the sample passed the leakage testing with no failure observed.All the 50 unopened samples passed the leakage testing as well.Bd determined that the cause of the failure is possibly related to our supplier¿s process.Our supplier has been notified of the failure observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD EXT SET 15CM SMALL BORE SPIN NUT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18346812
• Report Number: 9610847-2023-00350
• Device Sequence Number: 17478242
• Product Code: FPA
• UDI-Device Identifier: 00382903851515
• UDI-Public: (01)00382903851515
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2024

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: Other
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 385151
• Device Lot Number: 3055756
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 01/18/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/18/2024; 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown