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

Catalog Number 385100

Device Problem Leak/Splash (1354)

Patient Problems Vomiting (2144); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device tazocillin line leaked during use.The following information was provided by the initial reporter, translated from french: "occurrence of the incident: on (b)(6) 2023 at 04:30, the nurse found the child fully awake while she was receiving sedatives and curares.The child was 80% desaturated and vomiting.The nurse notices that there is liquid on the floor, under the syringe connections.She notices that there is a leak in the tazocillin line, between the two-way valve and the 1 metre connection.The nurse checks that the components are properly connected, but the leakage persists.The catheter pathway through which the medication passes, the proximal pathway, is no longer passing, and it appears that the medication is rising and escaping through this leak.Immediate action: change the tazocillin administration line.Switch all iv drugs to a different catheter route (distal route), install a taurolock lock on the proximal line, management of child's discomfort and agitation, increase ventilation parameters, retained device.Immediate consequences apparent: agitation, vomiting, desaturation.".

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 27-jan-2023.H5: imdrf annex e grid: e1032.H5: imdrf annex f grid: f2301.H6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one 60ml miscellaneous syringe and a q-syte assembly containing an extension tubing and a max-zero device.The q-syte unit was from an unknown lot number.A gross visual inspection was performed on the returned unit, and no defect could be found.As you experienced leakage, the septum was removed from the body of device and was further inspected for damage.A leak test was performed on the returned using a luer lock syringe.Leakage was observed through the vent holes of the top body.A tear was observed on the column wall.The reported issue of a leak in the q-syte connector was confirmed, but it could not be determined with certainty whether the column tear in the septum originated during manufacturing or use of the device.The type of tear column wall may occur during manufacturing due to misalignment or damaged/burred probes.This defect may also occur in the clinician environment during use due to excessive actuations or extraneous force on the septum.As the device has been opened and handled, it cannot conclusively be linked to either manufacturing or use as the defect would have the same appearance.

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device tazocillin line leaked during use.The following information was provided by the initial reporter, translated from french: "occurrence of the incident: on (b)(6) 2023 at 04:30, the nurse found the child fully awake while she was receiving sedatives and curares.The child was 80% desaturated and vomiting.The nurse notices that there is liquid on the floor, under the syringe connections.She notices that there is a leak in the tazocillin line, between the two-way valve and the 1 metre connection.The nurse checks that the components are properly connected, but the leakage persists.The catheter pathway through which the medication passes, the proximal pathway, is no longer passing, and it appears that the medication is rising and escaping through this leak.Immediate action: change the tazocillin administration line.Switch all iv drugs to a different catheter route (distal route) install a taurolock lock on the proximal line management of child's discomfort and agitation increase ventilation parameters retained device immediate consequences apparent: agitation, vomiting, desaturation".

• 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
• 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: 16219773
• MDR Text Key: 308851869
• Report Number: 9610847-2023-00005
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142527
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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