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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PMCF-Q-SYTE-VIAL-ACCESS; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD PMCF-Q-SYTE-VIAL-ACCESS; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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.Medical device expiration date: unknown.The customer's address is unknown.New (b)(6), usa has been used as a default.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.
 
Event Description
It was reported that unspecified bd¿ pmcf-q-syte-vial-access was damaged on 2 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via survey response that the clinician experienced vial access spike breaks during use (2).
 
Event Description
It was reported that unspecified bd¿ pmcf-q-syte-vial-access was damaged on 2 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via survey response that the clinician experienced vial access spike breaks during use (2).
 
Manufacturer Narrative
Investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
 
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Brand Name
UNSPECIFIED BD PMCF-Q-SYTE-VIAL-ACCESS
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11646176
MDR Text Key267148047
Report Number2243072-2021-01077
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 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
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
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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