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 Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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 16 bd q-syte¿ luer access split-septum stand-alone devices experienced an unglued septum/lifting at the rim.The following information was provided by the initial reporter: the qsyte¿s septum fell into the q-syte at the junction of the qsyte separation membrane when the rinsing tube was sterilized or when the syringe was connected.The department reported that similar incidents occurred many times.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-14.H6: investigation summary: our quality engineer inspected the samples and photos submitted for evaluation.Bd received two opened units with varying amounts of dried media and two photos.During the initial visual examination, it was observed that the septum of both units was pushed into the top body, confirming the reported defect.The units were microscopically inspected and found to have no voids in adhesive residue on the top disk and body, indicating an acceptable bond at the time of manufacture.No additional damage to the units was found during the microscopic inspection.The septum may become pushed in due to excessive force exerted on the septum in the clinical environment or during the manufacturing process.Bd was unable to determine a definite root cause since the devices had been used and no manufacturing defects were observed.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that 16 bd q-syte¿ luer access split-septum stand-alone devices experienced an unglued septum/lifting at the rim.The following information was provided by the initial reporter: the qsyte¿s septum fell into the q-syte at the junction of the qsyte separation membrane when the rinsing tube was sterilized or when the syringe was connected.The department reported that similar incidents occurred many times.

• 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: 11103111
• MDR Text Key: 227034923
• Report Number: 9610847-2020-00443
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: 9282204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1