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

Catalog Number	385164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
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¿ tri-extension set luer-lok collar got stuck in the lumen and broke during use.The following information was provided by the initial reporter, translated from german: "customer informed that during the care of a patient, the lower screw of art.385164 had come loose.He then instructed that the articles of the affected batch (which he could not name) be put aside and not used for the time being.According to the customer the product does not have a ¿screw (schraube)¿ we asked for clarification, and the customer described the following: ¿hub broke and got stuck in the lumen.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-dec-2022.H6: investigation summary: our quality engineer inspected the 1 sample and 1 photo submitted for evaluation.The reported issue of loose component - no leak was confirmed upon inspection of the sample.Analysis of the sample showed that tip of the extension was broken into another device, specifically the fitting connector.Bd determined that the cause of the failure was not associated to our manufacturing process.The failure shown by the sample is not reproducible in our manufacturing process.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.H3 other text : see h10.
Event or Problem Description
It was reported that the bd q-syte¿ tri-extension set luer-lok collar got stuck in the lumen and broke during use.The following information was provided by the initial reporter, translated from german: "customer informed that during the care of a patient, the lower screw of art.385164 had come loose.He then instructed that the articles of the affected batch (which he could not name) be put aside and not used for the time being.According to the customer the product does not have a ¿screw (schraube)¿ we asked for clarification, and the customer described the following: ¿hub broke and got stuck in the lumen¿.".

• Brand Name: BD Q-SYTE¿ TRI-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: 15561023
• Report Number: 9610847-2022-00388
• Device Sequence Number: 6575481
• Product Code: FPA
• UDI-Device Identifier: 00382903851645
• UDI-Public: (01)00382903851645
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/20/2023

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: 05/31/2023
• Device Catalogue Number: 385164
• Device Lot Number: 0164194
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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