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: BD CARIBE LTD. BD MICROTAINER® TUBE EXTENDER; BLOOD SPECIMEN COLLECTION DEVICE
  • 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
 

BD CARIBE LTD. BD MICROTAINER® TUBE EXTENDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 365976
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
 
Event Description
It was reported that the extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
 
Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to overly tight extenders as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD MICROTAINER® TUBE EXTENDER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key9774846
MDR Text Key191807133
Report Number2618282-2020-00013
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903659765
UDI-Public50382903659765
Combination Product (y/n)N
PMA/PMN Number
K931368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number365976
Device Catalogue Number365976
Device Lot Number9302569
Was Device Available for Evaluation? No
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-