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

Catalog Number 395246

Device Problem Leak/Splash (1354)

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

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the stpck q-syte red 360deg w/o nut cap ns leaked past the septum during use, wetting the patient's sheets.The patient was being treated with antibiotics.The following information was provided by the initial reporter, translated from (b)(6) to english: "after placed on a patient, gave antibiotics in the morning and in the evening.7-10 days later, hcp found a sheet was wet and the septum was sunk.".

Event Description

It was reported that the stpck q-syte red 360deg w/o nut cap ns leaked past the septum during use, wetting the patient's sheets.The patient was being treated with antibiotics.The following information was provided by the initial reporter, translated from japanese to english: "after placed on a patient, gave antibiotics in the morning and in the evening.7-10 days later, hcp found a sheet was wet and the septum was sunk.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-09.H.6.Investigation summary six picture samples and one used physical sample were provided for evaluation by our quality engineer team.Quality records cannot be consulted for tracking since the batch was not reported.In the complaint event description is stated that the stopcock was in use for 7-10 days, as is stated in the number 6 of the ifu the stopcock should be changed every 72 hours or 24 if the solution used has high ph.Through microscopic examination of the sample, it was determined that the septum component of the q-syte lifts up from the outer rim.The residual septum material and the adhesive was evident on the outer rim.Leakage testing was performed, however, no signs of leakage were observed.No further damages to the septum were observed.An exact cause for the septum separation from the rim could not be determined, however, it was confirmed that the septum was correctly bonded to the product through the identification of the residual septum material and adhesive.Based on the provided feedback, it appears that the product was working as intended for the first week of use.Our quality team will continue to monitor the production process for signs of potential defects and any emerging trends.

• Brand Name: STPCK Q-SYTE RED 360DEG W/O NUT CAP NS
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9935694
• MDR Text Key: 195313905
• Report Number: 9610847-2020-00125
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 05/29/2020

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: Health Professional
• Device Catalogue Number: 395246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other