MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ TRI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385158
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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 that medication leaked from the top of the bd q-syte¿ tri-extension set septum.This occurred with 5 sets during use.The following information was provided by the initial reporter: "not able to insert the syringes in the split septum.So that unable to give medication and also drug spill is happening.".
Event or Problem Description
It was reported that medication leaked from the top of the bd q-syte¿ tri-extension set septum.This occurred with 5 sets during use.The following information was provided by the initial reporter: "not able to insert the syringes in the split septum.So that unable to give medication and also drug spill is happening.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-apr-2023.H6: investigation summary it was reported the customer was unable to insert the syringes in the split septum which resulted in the inability to give medication and leakage.To aid in the investigation, three q-syte assemblies from lot 2033442 were received for evaluation by our quality team.A visual inspection was performed.The units have not been used but are not sealed in the packaging.A golf pin was used to identify the access through the units.During the insertion of the pin, it was determined that the disks on the units did not have slits on them.The septa are slit during the manufacturing process.If a septum is not slit, it may be a result of a broken blade, missing blade, or mixed product of non-slit septum with a slit septum.There is a 100% inspection during the lube station that checks for the presence of a slit.It could be possible that a no slit would pass if the station actuation force was set too high.Operators also inspect for no slit per the quality plan.A device history record review was completed for provided material number 385158, lot 2033442.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformances, capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Additional device histories were reviewed for each batch of units used in the manufacturing of this batch and no related quality issues or process deviations were found.The appropriate manufacturing personnel were notified of the complaint.Based on the investigation, the report that the q-syte connector could not be accessed was confirmed and the cause appeared to be manufacturing related.The septum on the q-syte connectors had not been slit, which prevented infusion of fluid through the connector and likely contributed to the reported drug spill.

• Brand Name: BD Q-SYTE¿ TRI-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 ; 8448235433
• MDR Report Key: 16740494
• Report Number: 9610847-2023-00086
• Device Sequence Number: 17817700
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: 00382903851584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/19/2023

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: 01/31/2025
• Device Catalogue Number: 385158
• Device Lot Number: 2033442
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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