MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE 15CM SMALL BORE TRI-EXT SETS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385158
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
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 3 bd q-syte 15cm small bore tri-ext sets were not able to prime.The following information was provided by the initial reporter: when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.
Event or Problem Description
It was reported that 3 bd q-syte 15cm small bore tri-ext sets were not able to prime.The following information was provided by the initial reporter: when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-dec-2022.H6: investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of flow issues - fluid blockage and connection issues were confirmed upon inspection of the samples.Analysis of the samples showed that the top membrane disks of 2 of the q-sytes on the sample did not have the proper slit openings.Bd determined that the cause of the failures was associated to the manufacturing process.During the manufacturing process the disks of the q-sytes have a slit cut into them via a blade.If the blade is dull, broken, or missing in the manufacturing machinery than the slit will not be properly cut into the disk resulting in flow issues and leakage.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.There were no nonconformance(s).H3 other text : see h10.

• Brand Name: BD Q-SYTE 15CM SMALL BORE TRI-EXT SETS
• 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: 15890379
• Report Number: 9610847-2022-00446
• Device Sequence Number: 5209990
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: 00382903851584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: 01/31/2025
• Device Catalogue Number: 385158
• Device Lot Number: 2033442
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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