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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

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 3 bd q-syte¿ luer access split-septum stand-alone devices experienced discoloration of the device.The following information was provided by the initial reporter: the head nurse found that there was a natural yellowing of the q-syte in the nearest joint¿ s septum and it was not used.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/14/2020.H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one q-syte and one photo displaying two q-syte units with apparent differences in septum color.During the visual examination of the returned unit it was observed that the silicon septum appeared to be yellow.Discoloration of the silicon septum can occur due to raw materials, during the adhesive curing step in manufacturing, or during sterilization, however no quality issues were found.Storage conditions can also contribute to discoloring of the septum.Although the failures stated in the reported issue were confirmed with the unit provided for investigation, bd could not establish a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that 3 bd q-syte¿ luer access split-septum stand-alone devices experienced discoloration of the device.The following information was provided by the initial reporter: the head nurse found that there was a natural yellowing of the q-syte in the nearest joint¿ s septum and it was not used.

• 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: 11098376
• MDR Text Key: 226856795
• Report Number: 9610847-2020-00439
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: 0006390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1