MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD Q-SYTE 15CM SMALL BORE TRI-EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385158
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 15cm small bore tri-ext set the packaging was damaged.There was no report of patient impact.The following information was provided by the initial reporter: customer has complained to rds on the damage of packing of one quantity of q syte small bore tri ext (b)(4).
Event or Problem Description
It was reported while using bd q-syte 15cm small bore tri-ext set the packaging was damaged there was no report of patient impact.The following information was provided by the initial reporter: customer has complained to rds on the damage of packing of one quantity of q syte small bore tri ext cat 385158.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-dec-2022.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of packaging issue - product packaging was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no abnormalities or damages on the returned sample.Functional testing, such as leakage testing, could not be performed since the sample was returned in a used state.Bd cannot determine a manufacturing related root cause since the defect reported could not be confirmed.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.

• Brand Name: BD Q-SYTE 15CM SMALL BORE TRI-EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15883653
• Report Number: 9616066-2022-01821
• Device Sequence Number: 5298395
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: 00382903851584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: NA
• 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): 12/29/2022

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: 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: 11/03/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/16/2023
• 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