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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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UNSPECIFIED BD¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).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 unspecified bd¿ infusion set tubing was expanded/bulged.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "two separate iv tubing reports.Rn noted the soft part of iv tubing has a bulge.".
 
Event Description
It was reported that the unspecified bd¿ infusion set tubing was expanded/bulged.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "two separate iv tubing reports.Rn noted the soft part of iv tubing has a bulge.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 8/30/2021.H.6.Investigation: one sample and one photo were returned by the customer.It was reported iv tubing has a bulge.The photo shows two incomplete tubing sets that appear to have a bulge/bubble in their pumping segments.The customer complaint can be verified.The returned sample was examined for defects and abnormalities.The returned sample is not a complete set.The portion of tubing that was returned is from the back check valve to the second smartsite.Therefore, an infusion could not be completed and accurate model and lot numbers could not be identified.A device history record review could not be performed because a model number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED BD¿ INFUSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12363491
MDR Text Key268053144
Report Number2243072-2021-02168
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Yes
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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