MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device leaked morphine during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about leakage from q-syte.During administration of morphine for a patient with breathing difficulty, using q-syte connected to a terumo¿s syringe (luer lock type), leakage (morphine) occurred.".

Manufacturer Narrative

H6: investigation summary.Our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used q-syte unit without packaging and four photos of a unit that resembles the returned unit.During the visual examination it was observed that there were no anomalies or damage to the external areas of the q-syte.Further microscopic analysis of the unit revealed that there was a tear at the column wall of the septum near the vent hole.The leakage test was performed on the unit in the unactuated and actuated positions.Leakage did not occur in the unactuated position.Leakage did occur through the vent hole in the actuated position confirming the reported issue.The observed column tear in the unit contributed to the leakage from the vent hole.This type of damage can occur in the user environment because of excessive actuations and/or extraneous force but the exact root cause could not be determined.A device history record review could not be performed as the lot number is unknown.H3 other text : see h.10.

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device leaked morphine during use.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about leakage from q-syte.During administration of morphine for a patient with breathing difficulty, using q-syte connected to a terumo¿s syringe (luer lock type), leakage (morphine) occurred.".

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• 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
• MDR Report Key: 10715231
• MDR Text Key: 214828510
• Report Number: 9610847-2020-00329
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other