MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT; STOPCOCK

Catalog Number 394501

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that the connecta q-syte wht experienced leakage.The following information was provided by the initial reporter: this concerns the robinet 3v + valve bidirectionnelle bd q-syte reference: (b)(4).In the first case, it is an incident that occurred during the passage of a red blood cell, in the haematology department.A leak at the 3-way valve was noticed in the first 10 minutes of the passage of the red cell pellet.The valve had to be changed.In the first case on (b)(6), the patient was to receive anti-lymphocyte serum but due to excessive leakage during administration, the treatment was stopped.Unfortunately, the packaging of the device has not been preserved and the batch number is unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-12-15 h6: investigation summary to aid in the investigation of this incident, the affected sample was returned for evaluation by our quality engineer team.Due to preventive restrictions in place for safety regarding covid, the returned sample was only visually inspected.Through visual inspection no signs of defect could be identified.If additional feedback was provided to further detail the location of the leakage, further investigation could be conducted.Dhr review was not performed because batch was not provided.

Event Description

It was reported that the connecta q-syte wht experienced leakage.The following information was provided by the initial reporter: this concerns the robinet 3v + valve bidirectionnelle bd q-syte reference: 394501.In the first case, it is an incident that occurred during the passage of a red blood cell, in the haematology department.A leak at the 3-way valve was noticed in the first 10 minutes of the passage of the red cell pellet.The valve had to be changed.In the first case on october 10, the patient was to receive anti-lymphocyte serum but due to excessive leakage during administration, the treatment was stopped.Unfortunately, the packaging of the device has not been preserved and the batch number is unknown.

• Brand Name: CONNECTA Q-SYTE WHT
• 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: 10962392
• MDR Text Key: 226855858
• Report Number: 9610847-2020-00398
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1