MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE); INTRAVASCULAR ADMINISTRATION SET

Catalog Number PMCF-BDQSYTELUERACCESS-2023

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.

Event Description

It was reported that the unspecified bd q-syte¿ luer access split septum (stand-alone device) the customer experienced fluid blockage.The following information was provided by the initial reporter, translated from spanish to english: verbatim: clinician experienced: fluid blockage -intravascular administration of fluids and/or medication - low permeability.

• Brand Name: UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18012490
• MDR Text Key: 326677403
• Report Number: 2243072-2023-01935
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PMCF-BDQSYTELUERACCESS-2023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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