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 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the connecta q-syte wht experienced leakage.The following information was provided by the initial reporter: complaint 2 of 2 this concerns the robinet 3v + valve bidirectionnelle bd q-syte reference: (b)(4).On (b)(6), the leak occurred at the beginning of the passage of globular pellets.The tap was changed and treatment could be administered.The device came into contact with blood.

Event Description

It was reported that the connecta q-syte wht experienced leakage.The following information was provided by the initial reporter: complaint 2 of 2 this concerns the robinet 3v + valve bidirectionnelle bd q-syte reference: (b)(4).On 30 october, the leak occurred at the beginning of the passage of globular pellets.The tap was changed and treatment could be administered.The device came into contact with blood.

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.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 damage, cracking, or any defect could be identified.If additional feedback was provided to further detail the location of the leakage, further investigation could be conducted.At this time, further action has not been determined necessary at the manufacturing facility.Dhr review was not performed because batch was not provided.

• 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: 10973446
• MDR Text Key: 220453447
• Report Number: 9610847-2020-00402
• 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

• 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
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1