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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONNECTA PLUS3 WHITE PEGS; CATHETER
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CONNECTA PLUS3 WHITE PEGS; CATHETER Back to Search Results
Catalog Number 394601
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
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 connecta plus3 white pegs had air bubbles.The following information was provided by the initial reporter: additional information per related complaint: we have been informed of a malfunction when using a 3v ll connecta rot 360°.Indeed, our neonatology department reports that 4 hours after the assembly of the nutrition tree including your tap, bubbles of a consequent size appeared in the tubing and dispersed in the extension.However, the purge was carried out before connection.This event occurred 5 times in the year 2021 with different breakers and pumps.
 
Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.
 
Event Description
It was reported that connecta plus3 white pegs had air bubbles.The following information was provided by the initial reporter: additional information per related complaint: we have been informed of a malfunction when using a 3v ll connecta rot 360°.Indeed, our neonatology department reports that 4 hours after the assembly of the nutrition tree including your tap, bubbles of a consequent size appeared in the tubing and dispersed in the extension.However, the purge was carried out before connection.This event occurred 5 times in the year 2021 with different breakers and pumps.
 
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Brand Name
CONNECTA PLUS3 WHITE PEGS
Type of Device
CATHETER
MDR Report Key12125712
MDR Text Key260219792
Report Number9610847-2021-00305
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394601
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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