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 Problems Material Discolored (1170); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd q-syte luer access split-septum stand-alone device was discolored before being unpacked.This occurred on 5 separate occasions.No serious injury or medical intervention was reported.

Event Description

It was reported that bd q-syte¿ luer access split-septum stand-alone device was discolored before being unpacked.This occurred on 5 separate occasions.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: during dhr review: all challenge, set up and in process samples were performed per control plans and all passed per specifications.No qn¿s were initiated during production.Received one q-syte unit within a sealed package from lot number 6064848.The septum of the q-syte unit received displayed a yellow discoloration-tint.No other anomalies were found.The submitted photographs displayed similarities of a yellow discoloration as did the returned unit.A definite source that contributed to the yellowing discoloration of the septum could not be established.Contributive factors for this defect could be the storage condition of the end user.

• 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
• MDR Report Key: 8324395
• MDR Text Key: 136009130
• Report Number: 9610847-2019-00139
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 385100
• Device Lot Number: 6064848
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other