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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 Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 had flow issues and over-infused during use.The following information was provided by the initial reporter: "if suspected overinfusion, pause pump and power down-keep all tubing sets in place.".
 
Event Description
It was reported that the unspecified bd¿ infusion set had flow issues and over-infused during use.The following information was provided by the initial reporter: "if suspected overinfusion, pause pump and power down-keep all tubing sets in place.".
 
Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the suspect over-infused could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED BD¿ INFUSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12236247
MDR Text Key265218163
Report Number2243072-2021-01970
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 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 Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/28/2021
Initial Date FDA Received07/28/2021
Supplement Dates Manufacturer Received08/17/2021
Supplement Dates FDA Received09/02/2021
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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