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

Model Number	385163
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd q-syte¿ bi-extension sets connection to the syringe broke.The following information was provided by the initial reporter, translated from (b)(6) to english: "broken 5 ml syringe from set q-syte (octopus)" "after investigating the complaint material, we came to the conclusion that it was not the 5ml syringe but the connection of one of the q sytes.".
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension sets connection to the syringe broke.The following information was provided by the initial reporter, translated from dutch to english: "broken 5 ml syringe from set q-syte (octopus)." "after investigating the complaint material, we came to the conclusion that it was not the 5ml syringe but the connection of one of the q sytes.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-17.H6: investigation summary: a complaint of component damage on the q-syte was received from the customer.A sample was provided by the customer to aid in the investigation of this defect.Through investigation, the customer complaint was confirmed.Damage was found on the q-syte.A device history record review was completed by our quality engineer team for provided lot number 0121421.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The manufacturing process was reviewed to see where this defect could have occurred and the failure was not replicated.The probable root cause for this defect is incorrect product use.A quality alert has been created to alert the plant of this problem, and all involved personnel were emailed to be made aware of this issue.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

• Brand Name: BD Q-SYTE BI-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
• MDR Report Key: 11402999
• Report Number: 9610847-2021-00090
• Device Sequence Number: 16989624
• Product Code: FPA
• UDI-Device Identifier: 50382903851633
• UDI-Public: 50382903851633
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 04/30/2023
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: 0121421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1