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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTROSYTE¿ INTRODUCER; CATHETER INTRODUCER

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BECTON DICKINSON UNSPECIFIED BD INTROSYTE¿ INTRODUCER; CATHETER INTRODUCER Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem Bruise/Contusion (1754)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown: (b)(6) usa has been used as a default.  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.(b)(4).
 
Event Description
It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
 
Manufacturer Narrative
H.6.Investigation: bd  was unable to  perform a thorough investigation as no 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.
 
Event Description
It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown; batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
 
Manufacturer Narrative
The following field was updated due to correction: h: no.Of events summarized: 3.
 
Event Description
It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
 
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Brand Name
UNSPECIFIED BD INTROSYTE¿ INTRODUCER
Type of Device
CATHETER INTRODUCER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11143603
MDR Text Key226016300
Report Number2243072-2021-00068
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/25/2022
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received01/09/2021
Supplement Dates Manufacturer Received01/29/2021
07/08/2022
Supplement Dates FDA Received01/31/2021
07/29/2022
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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