MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH SMALL BORE BI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385163
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd q-syte¿ needle-free connector with small bore bi-extension set , the device experienced an occlusion.The following information was provided by the initial reporter.The customer stated: when reported occlusion was observed? on (b)(6) 2022.How was the procedure finished? after occlusion it was simply stopped customer reported occlusion.
Event or Problem Description
It was reported when using the bd q-syte¿ needle-free connector with small bore bi-extension set , the device experienced an occlusion.The following information was provided by the initial reporter.The customer stated: when reported occlusion was observed? on 5-jan-2022.How was the procedure finished? after occlusion it was simply stopped.Customer reported occlusion.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-feb-2022.H.6.Investigation: our quality engineer inspected the 2 samples submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.During inspection of the two samples, one was found to have a pushed in septum with multiple tears on the septum disk.The other sample was found to be within proper manufacturing specification.The damaged sample could not be tested because the pushed in septum prevented testing from happening properly.The undamaged sample underwent our internal flow testing and was found to be operating properly with no defects.No manufacturing root cause could be determined for the flow issue ¿ fluid blockage defect since the defect was not confirmed in testing.The damaged sample was also examined for any defects in the adhesion process of production, but no gaps in adhesion were observed, so the product was properly assembled during production.Bd determined that the most probable cause of the septum being pushed in was application error of the device, most likely related to excessive force applied.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH SMALL BORE BI-EXTENSION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13423011
• Report Number: 9610847-2022-00037
• Device Sequence Number: 11750575
• Product Code: FPA
• UDI-Device Identifier: 00382903851638
• UDI-Public: 00382903851638
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 06/30/2024
• Device Catalogue Number: 385163
• Device Lot Number: 1193264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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