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

Model Number	385101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd q-syte¿ extension set had leakage at the luer connection.The following information was provided by the initial reporter: "leakage blood between catheter and hub, normal after change a new connector.".
Event or Problem Description
It was reported bd q-syte¿ extension set had leakage at the luer connection.The following information was provided by the initial reporter: "leakage blood between catheter and hub, normal after change a new connector.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the one photo submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the photo.The photo did not show any damages or abnormalities on the sample product.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported bd q-syte¿ extension set had leakage at the luer connection.The following information was provided by the initial reporter: "leakage blood between catheter and hub, normal after change a new connector".
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: 22-jul-2022.H.6.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the sample.The sample underwent our internal leakage testing, and the sample did not show any signs of leakage.No damages were observed on the sample as well.The device history records (dhr) review was performed for the lot number material identified in this complaint.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), capa¿s or abnormal conditions noted at the time of production.Bd cannot determine a cause of the failure since the failure was not confirmed.H3 other text : see h.10.

• Brand Name: BD Q-SYTE¿ 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: 14311677
• Report Number: 9610847-2022-00173
• Device Sequence Number: 4794972
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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: 03/31/2026
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: 1113054
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 08/08/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/26/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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