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	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd q-syte extension set leaked.The following information was provided by the initial reporter: blood leakage from hub.Seems broken when check with eyes.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default initial reporter name and address; initial reporter phone #: b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of leakage was confirmed upon inspection and testing of the sample.The sample underwent our internal leakage testing and leakage was observed.Further examination of the sample also showed a crack on the sample.Bd was unable to reproduce the defect in our manufacturing process so no manufacturing related root cause could be identified.The major contributor to leakage is the occurrence of cracks in the product.The appearance of cracks is typical for when the product has been used together with a lubrication solution or infusion with high ph-value.These solutions can release internal stresses in the product, resulting in cracks if excessive force is used when connecting and using the product for more than 24 hours.The device history records (dhr) review was performed for the lot number material identified in this complaint.H3 other text : see h10.
Event or Problem Description
It was reported that while using the bd q-syte extension set leaked.The following information was provided by the initial reporter: blood leakage from hub.Seems broken when check with eyes.

• 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: 15218843
• Report Number: 9610847-2022-00301
• Device Sequence Number: 6672870
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/09/2022
• 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