MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE; INTRAVASCULAR ADMINISTRATION SET

Model Number	385101
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd q-syte extension set 15 cm (6 in) 1.14 ml std bore the tubing deformed during use.There was no report of patient impact.The following information was provided by the initial reporter: tube deformation when priming medication.
Event or Problem Description
It was reported while using bd q-syte extension set 15 cm (6 in) 1.14 ml std bore the tubing deformed during use.There was no report of patient impact.The following information was provided by the initial reporter: tube deformation when priming medication.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-feb-2022.H6: investigation summary our quality engineer inspected the 1 sample and 2 photos submitted for evaluation.The reported issue was confirmed upon inspection of the sample.During inspection it was seen that the tubing of the sample had burst.Bd determined that the cause of the failure was a result of exceeding the pressure allowed by the product.The product is designed not to leak at pressures below 45 psi or at 20 psi after 100 actuations.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD Q-SYTE EXTENSION SET 15 CM (6 IN) 1.14 ML STD BORE
• 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: 13592236
• Report Number: 9610847-2022-00076
• Device Sequence Number: 20349068
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 1082694
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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