MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE - STANDALONE INDIA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	385103
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is a result of an investigation finding: a device history record review showed no non-conformances associated with this issue during the production of this batch.Bd received one unsealed q-syte unit.Additionally, one photo was provided.The photo displays the q-syte unit with blood inside the housing.Visual inspection of the physical sample confirmed what the photo displays.The unit was dissected and inspected.The slit on the top body appeared to not be centered correctly.With the slit not centered properly, the connection cannot be made through the septum properly.The connection will only go through the top body, resulting in the fluid not flowing through the septum correctly.The reported nonconformance has been confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error in the packaging process.This type of defect may occur during manufacturing due to a misalignment failing to properly fix the septum in place during alteration.Blade quality and slit dimensions are checked regularly during production to monitor and addresses this issue.The appropriate personnel have been notified and complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that bd q-syte - standalone india septum damaged identified during device investigation.The following information was provided by the initial reporter: after attached new q-syte stand alone, blood enters below the septum area, even after flushing, blood stuck as it is.No course of treatment changed.Pharmacy replace the particular unit.Investigation finding: septum damage lead to observed leak.

• Brand Name: BD Q-SYTE - STANDALONE INDIA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19752128
• Report Number: 1710034-2024-00726
• Device Sequence Number: 6606323
• Product Code: FPA
• UDI-Device Identifier: 00382903851034
• UDI-Public: (01)00382903851034
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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: 385103
• Device Lot Number: 3289622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown