MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHITE 360DEG SHELF 100EA INDIA; STOPCOCK

Catalog Number 395000

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2021

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 catheter was difficult to insert into the connecta white 360deg shelf 100ea (b)(6) , which eventually came loose from the cannula and leaked out medicine.The following information was provided by the initial reporter: "venflon i is hard to insert and sometimes she feel like it double puncture.Connecta plain is getting loose from the cannula after some time and medications are leaking due to this.".

Event Description

It was reported that the catheter was difficult to insert into the connecta white 360deg shelf 100ea india, which eventually came loose from the cannula and leaked out medicine.The following information was provided by the initial reporter: "venflon i is hard to insert and sometimes she feel like it double puncture.Connecta plain is getting loose from the cannula after some time and medications are leaking due to this.".

Manufacturer Narrative

H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: CONNECTA WHITE 360DEG SHELF 100EA INDIA
• 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: 12263732
• MDR Text Key: 264700494
• Report Number: 9610847-2021-00356
• 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: 08/04/2021

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: Health Professional
• Device Catalogue Number: 395000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1