MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 380510

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that there was leakage of cytotoxic drugs from the bd q-syte¿ luer access split septum.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Although units were not received a photo was provided for observation.The photo revealed the q-syte was attached to a stop-cock and appeared to be intact.The photo did not provided sufficient evidence to identify the failure or determine a root cause.A review of the device history record could not be performed as a lot number was not provided for this incident.Without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6846852
• MDR Text Key: 85300208
• Report Number: 1710034-2017-00174
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 380510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 11/01/2017
• 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
• Patient Outcome(s): Other