MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. STPCK Q-SYTE RED 360DEG W/O NUT CAP NS

Catalog Number 395246

Device Problem Leak/Splash (1354)

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

Event Date 04/11/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that stpck q-syte red 360deg w/o nut cap ns septum was detached.This was discovered during use.The following information was provided by the initial reporter: on april 8th, started to use on patient.Since then, some hcps gave drugs.On april 11th, hcp found a surface of the septum was detached when injecting drug from the side tube(patient side).Hcps used luer lock or slip.

Event Description

It was reported that stpck q-syte red 360deg w/o nut cap ns septum was detached.This was discovered during use.The following information was provided by the initial reporter: on april 8th, started to use on patient.Since then, some hcps gave drugs.On april 11th, hcp found a surface of the septum was detached when injecting drug from the side tube(patient side).Hcps used luer lock or slip.

Manufacturer Narrative

H.6.Investigation: one physical sample and five picture samples were provided for evaluation by our quality engineer team.Through examination of the sample, the septum component was observed damaged.The septum component of the stopcock product is supplied by another manufacturing facility, however, as the lot number was unknown for this product, a review of the production history could not be completed.It is possible that the damaged septum was a result of the manufacturing equipment, however, this cannot be confirmed.The machine was reviewed to find if this damage could be produced by the machine, however, a possible root cause was not found for the defect.H3 other text : see h.10.

• Brand Name: STPCK Q-SYTE RED 360DEG W/O NUT CAP NS
• 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 ; MX
• MDR Report Key: 10027242
• MDR Text Key: 195431469
• Report Number: 9610847-2020-00149
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 395246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other