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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 the pm line disconnected from the bd q-syte¿ tri-extension set while trying to insert it.The following information was provided by the initial reporter: "in iccu, when the pm line was tried to be inserted with one of the extension of the q-syte tri-ext, the pm line was getting pop-out and not fixing when rotating".
Additional Manufacturer Narrative
H6: investigation summary: it was reported the line was popping out and not fixing when rotating.As a sample was not returned, a thorough sample investigation could not be completed.An evaluation of the actual device would be necessary to confirm the reported failure mode.A device history record review was completed for provided material number 385158, lot 3032599.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 nonconformance(s), 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 q-sytes used in the manufacturing of this batch and no related quality issues or deviations were found during the manufacturing of the subassembly batch.Based on the investigation, bd was not able to confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that the pm line disconnected from the bd q-syte¿ tri-extension set while trying to insert it.The following information was provided by the initial reporter: "in iccu, when the pm line was tried to be inserted with one of the extension of the q-syte tri-ext, the pm line was getting pop-out and not fixing when rotating".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17503248
• Report Number: 9610847-2023-00228
• Device Sequence Number: 14064088
• 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): 08/29/2023

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: 01/31/2026
• Device Catalogue Number: 385158
• Device Lot Number: 3032599
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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