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

Catalog Number 385100

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the leur tip of a bd q-syte¿ luer access split-septum stand-alone device broke "making removal of the bd syringe impossible".There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

Event Description

It was reported that the leur tip of a bd q-syte luer access split-septum stand-alone device broke "making removal of the bd syringe impossible".There was no report of exposure, injury or medical intervention.

Event Description

It was reported that the leur tip of a bd q-syte¿ luer access split-septum stand-alone device broke "making removal of the bd syringe impossible".There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: received one used q-syte unit attached to a bd posiflush xs syringe.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of luer lok collar breakage with lot #7272681 regarding item #385100.The dhr reviews were performed on the sub-assembly lot numbers.7251840 was built on qfa line 4, from september 17, 2017, thru september 19,2017.7258516 was built on qfa line 3, from september 17, 2017, thru september 19,2017.Review of the dhrs revealed all required challenges samples, set-up and in-process testing was performed per specification in accordance with the quality sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Root cause for this incident is indeterminate.A definite cause that contributed to the separation of the female connection site from the remainder of the top body could not be determined.Prolonged contact with incompatible medications or cleaning solutions may have contributed to the polycarbonate damage.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: Q-SYTE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7658471
• MDR Text Key: 113187307
• Report Number: 9610847-2018-00172
• 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,Followup
• Report Date: 08/17/2018

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: 09/30/2022
• Device Catalogue Number: 385100
• Device Lot Number: 7272681
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/11/2018; 06/11/2018
• Supplement Dates FDA Received: 08/16/2018; 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other