MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD EXT SET 15CM SMALL BORESPIN 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	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 borespin nut luer fittings incompatible.Mawar medical centre seremban's general ward has started to use q-syte extension 385151 on adult patients.They noticed there are incidence of loose spin nut after a period of time or after patient movement despite screwing and securing it completely.They have tried to put a plaster to secure the spin nut connection, but it became loose over time too.Customer is worried on the risk of q-syte extension set dislodge from patient's iv catheter (vasofix) during the night which may cause bleeding without the awareness of healthcare professionals.Moreover, they are using unigloves' 5ml luer lock syringe to give medication to patients and the syringe can be easily dislodge from the q-syte needle free connector.It is unable to lock completely whereby they can continuously screw the syringe to q-syte needle free connector endlessly and unable to lock it.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of luer fittings incompatible was not confirmed upon inspection of the samples.Analysis of the sample showed a non-bd syringe with the bd q-syte extension set connected.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the photo samples and a physical sample is needed to do a full investigation.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.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.
Event or Problem Description
No additional information.

• Brand Name: BD EXT SET 15CM SMALL BORESPIN 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: 20229414
• Report Number: 9610847-2024-00260
• Device Sequence Number: 3505053
• Product Code: FPA
• UDI-Device Identifier: 00382903851515
• UDI-Public: (01)00382903851515
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 06/30/2026
• Device Catalogue Number: 385151
• Device Lot Number: 3193733
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown