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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED INTROSYTE INTRODUCER SURVEY JP024; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED INTROSYTE INTRODUCER SURVEY JP024; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem Hematoma (1884)
Event Date 12/10/2020
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.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.(b)(4).".
 
Event Description
It was reported that 2 unspecified introsyte introducer survey jp024 had the sheath not split as intended during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced hematoma, and difficulties with the splittable sheath not completely separating.".
 
Event Description
It was reported that 2 unspecified introsyte introducer survey jp024 had the sheath not split as intended during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced hematoma, and difficulties with the splittable sheath not completely separating.See attached excel file for complaint details.".
 
Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no material number, 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.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED INTROSYTE INTRODUCER SURVEY JP024
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11141125
MDR Text Key225826936
Report Number2243072-2021-00033
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 health professional,other
Type of Report Initial,Followup
Report Date 01/29/2021
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 Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received01/08/2021
Supplement Dates Manufacturer Received01/29/2021
Supplement Dates FDA Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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