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

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 307704975
• Report Number: 9616066-2022-01821
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385158
• Device Lot Number: 2033442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1