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

Catalog Number 385157

Device Problem Failure to Deliver (2338)

Patient Problem Discomfort (2330)

Event Date 12/25/2022

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¿ microbore bi-extension there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: during a procedure in cath-lab, when the consultant was trying to push some medication in one of the port while the other port was connected to continuous iv fluid in qsyte bi-extention.The medication was back flowing in the other lumen connected to continuous iv line.

Event Description

It was reported while using bd q-syte¿ microbore bi-extension there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: during a procedure in cath-lab, when the consultant was trying to push some medication in one of the port while the other port was connected to continuous iv fluid in qsyte bi-extention.The medication was back flowing in the other lumen connected to continuous iv line.

Manufacturer Narrative

H6: investigation summary since no photos or samples displaying the reported condition of flow issues - back flow were available for examination, we were unable to fully investigate this incident.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).

• Brand Name: BD Q-SYTE¿ MICROBORE BI-EXTENSION
• Type of Device: 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: 16152467
• MDR Text Key: 308148479
• Report Number: 9610847-2022-00518
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385157
• Device Lot Number: 2111734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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