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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GP SERIES INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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GP SERIES INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 60593
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is dc be temse (temporary).This site is an oem manufacturing site.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.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 gp series infusion set had foreign matter.This occurred on 7 occasions.The following information was provided by the initial reporter: black fibers have been observed in manufacturing on the needle cover of angiocath.40 items were inspected.
 
Event Description
It was reported that gp series infusion set had foreign matter.This occurred on 7 occasions.The following information was provided by the initial reporter: black fibers have been observed in manufacturing on the needle cover of angiocath.40 items were inspected.
 
Manufacturer Narrative
Correction: this complaint will be cancelled.This is a duplicate complaint of mfr report # 9610847-2021-00428 & 9610847-2021-00429 that have already been reported for malfunction.
 
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Brand Name
GP SERIES INFUSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12543736
MDR Text Key273774813
Report Number9616066-2021-52134
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number60593
Device Lot Number1016731
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2021
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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