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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONNECTA PLUS3 BLUE BLEND; INTRAVASCULAR ADMINISTRATION SET
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CONNECTA PLUS3 BLUE BLEND; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 394901
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that connecta plus3 blue blend cap was missing.The following information was provided by the initial reporter: this is a report about a missing cap of connecta.According to the customer's report, it was confirmed that there was no cap on the male luer component.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/2/2021.H.6.Investigation: bd received a sample and photos submitted for evaluation.The reported issue was confirmed upon inspection of the sample and photos.Bd determined the root cause of the issue to be human error during the manual filling step of the product;s packaging.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
 
Event Description
It was reported that connecta plus3 blue blend cap was missing.The following information was provided by the initial reporter: this is a report about a missing cap of connecta.According to the customer's report, it was confirmed that there was no cap on the male luer component.
 
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Brand Name
CONNECTA PLUS3 BLUE BLEND
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12297844
MDR Text Key265838392
Report Number9610847-2021-00359
Device Sequence Number1
Product Code FPA
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 08/17/2021
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 Expiration Date06/30/2023
Device Catalogue Number394901
Device Lot Number0183737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Initial Date Manufacturer Received 07/12/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received08/17/2021
Supplement Dates FDA Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2020
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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