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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ NEEDLE BNS TUOHY OPEN SHLD; ANESTHESIA CONDUCTION NEEDLE
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BD CARIBE LTD. BD¿ NEEDLE BNS TUOHY OPEN SHLD; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Catalog Number 405482
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
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 with the use of the bd¿ needle bns tuohy open shld there was an issue with incorrect needle length.It was stated ¿while performing the incoming inspection for this batch, the inspector found that the length of the bevel appeared to be much longer than noted on the graphic bevel length listed as.120 +/-.005.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Investigation summary: ten samples of catalog 405482 were receive to bd juncos on 20jun18.Samples included all assembly components, such as needle and stylet (17ga x 3 1/2in tuohy) and the plastic shield.Four out of ten values were out of specification.However, per bd juncos internal procedure finish point length measurement is a reference length, that it means that finish point length is not a critical specification and do not impact the quality or function of the product if the required dimensions are within spec.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: possible root cause may be related to the manufacturing process at supplier site.
 
Event Description
It was reported with the use of the bd¿ needle bns tuohy open shld there was an issue with incorrect needle length.It was stated ¿while performing the incoming inspection for this batch, the inspector found that the length of the bevel appeared to be much longer than noted on the graphic bevel length listed as.120 +/-.005.¿ there was no report of injury or further medical intervention.
 
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Brand Name
BD¿ NEEDLE BNS TUOHY OPEN SHLD
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
MDR Report Key7589269
MDR Text Key111019636
Report Number2618282-2018-00024
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Catalogue Number405482
Device Lot Number7342831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/11/2018
Supplement Dates Manufacturer Received05/30/2018
Supplement Dates FDA Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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