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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd q-syte extension set 15 cm (6 in) 1.14 ml std bore leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: blood leakage from port.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, 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 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: blood leakage from port.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-feb-25 h6: investigation summary: our quality engineer inspected the 2 samples submitted for evaluation.The reported issue was confirmed upon inspection and testing of the samples.The sample underwent our internal leakage testing, and one of the two samples showed leakage.Upon further inspection of the defected sample, cracks were observed on the female connector of the extension.Bd cannot determine a manufacturing root cause since the failure cannot be replicated in our manufacturing process.The most probable root cause could be excessive force applied to the connector after use with a lubrication agent or high ph value infusion.Using such materials with the product can cause internal stresses to release and result in cracking at the connector when excessive force is applied.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.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: 13368850
• Report Number: 9610847-2022-00029
• Device Sequence Number: 17474675
• 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): 02/17/2022

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: 01/10/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/31/2022
• 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