Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD SUREPATH¿ COLLECTION VIAL; CYTOLOGY SPECIMEN CONTAINER IVD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRIPATH IMAGING, INC BD SUREPATH¿ COLLECTION VIAL; CYTOLOGY SPECIMEN CONTAINER IVD Back to Search Results
Model Number 491452
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the label on the bd surepath¿ collection vial tore when peeling it off.This occurred with 500 units before use.The following information was provided by the initial reporter, translated from japanese: "the label tore when peeling off to use due to a strongly adhered label," "the label with 2d barcode which attached on each vial.They peel off 2d barcode label for usage.".
 
Event Description
It was reported that the label on the bd surepath¿ collection vial tore when peeling it off.This occurred with 500 units before use.The following information was provided by the initial reporter, translated from japanese: "the label tore when peeling off to use due to a strongly adhered label," "the label with 2d barcode which attached on each vial.They peel off 2d barcode label for usage.".
 
Manufacturer Narrative
H6: investigation summary: the problem reported by the customer for fea vial 491452 lot number 1321543 was for the label tearing when 2d barcode is peeled.A complaint review for 491452 lot # 1321543 was performed.No previous complaints for 2d barcode tearing when peeled off or being difficult to peel were observed for the lot number.However, previous complaints for 2d barcode being difficult to peel were observed.Production of material 491452 lot 1321543 started on 19 nov 2021 at the bd mebane, nc production facility.(b)(4).The review of the manufacturing dhr for the lot number identified that it was complete and accurate with no indication of abnormal activities during manufacturing.A return sample of 50 vials from the lot was provided.An analysis of the returned sample confirmed that the 2d barcode is tearing when it is peeled from the vial.Additionally, a retain analysis was performed on one clamshell (25 vials).Although it was difficult to get the label to start to peel, no tearing was observed as the label was peeled from the vial.No definitive root cause could be established for the 2d barcode tearing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SUREPATH¿ COLLECTION VIAL
Type of Device
CYTOLOGY SPECIMEN CONTAINER IVD
Manufacturer (Section D)
TRIPATH IMAGING, INC
1022 corporate park drive
mebane NC 27302
Manufacturer (Section G)
TRIPATH IMAGING, INC
1022 corporate park drive
mebane NC 27302
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13965939
MDR Text Key298137720
Report Number3008007472-2022-00004
Device Sequence Number1
Product Code MKQ
UDI-Device Identifier10382904914520
UDI-Public10382904914520
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P970018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/14/2022
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 Model Number491452
Device Catalogue Number491452
Device Lot Number1321543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received03/31/2022
Supplement Dates Manufacturer Received06/14/2022
Supplement Dates FDA Received06/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-