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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 Problems Product Quality Problem (1506); Structural Problem (2506)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2018
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 that the while performing the incoming inspection for the bd¿ needle bns tuohy open shld batch, "the inspector found that the length of the bevel appeared to be much longer than the master sample.Upon further investigation, the graphic has the bevel length listed as.120 +/-.005 (default tolerance in legend on the graphic).The 20 that were tested for functional testing were measured on the comparator and were measuring between.130 and.151 which is out of tolerance.All 80 that were inspected throughout this lot appeared to be much longer than the master sample." found before use.No reports of serious injury or medical intervention noted.
 
Event Description
It was reported that the while performing the incoming inspection for the bd¿ needle bns tuohy open shld batch, "the inspector found that the length of the bevel appeared to be much longer than the master sample.Upon further investigation, the graphic has the bevel length listed as.120 +/-.005 (default tolerance in legend on the graphic).The 20 that were tested for functional testing were measured on the comparator and were measuring between.130 and.151 which is out of tolerance.All 80 that were inspected throughout this lot appeared to be much longer than the master sample." found before use.No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
 
Event Description
It was reported that the while performing the incoming inspection for the bd¿ needle bns tuohy open shld batch, "the inspector found that the length of the bevel appeared to be much longer than the master sample.Upon further investigation, the graphic has the bevel length listed as.120 +/-.005 (default tolerance in legend on the graphic).The 20 that were tested for functional testing were measured on the comparator and were measuring between.130 and.151 which is out of tolerance.All 80 that were inspected throughout this lot appeared to be much longer than the master sample." found before use.No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: ten samples of catalog 405482 were receive to bd juncos on (b)(6) 2018.Samples included all assembly components, such as needle and stylet (17ga x 3 1/2in tuohy) and the plastic shield.Cannula 17ga 3-1/2in tw part number 31442 is purchase from columbus and visual and dimensional testing are done as per procedure.A review of the device history record was completed for lot #7342831.This lot was manufactured from 11dec17 to 12dec17 on lawton machine under sub-assembly part no.405482 order 105603553.The inspections related to length measurements were the effective length and visual 10x test.Tests are performed during shift startup (16 units) and every 4 hours.Final inspection by quality was performed on 13dec17.According to the inspection record bdm0180, visual and functional characteristics were in compliance with the specification.Lot was released for packaging (b)(6) 2017 and packed as a bulk on (b)(6) 2017 as 405482 lot 7342831 order#105603553.The expiration date for this lot is 31 dec 2022.A total of 16,000 units were released on (b)(6) 2017.No machine interventions, breakdowns, qn¿s and/or ncmrs were reported for this lot.Preventive maintenance on the lawton machine was conducted as per schedule.Review of instrument calibrations included in the inspection records was conducted and they were calibrated within their calibration due dates.Samples tested showed four out of ten values were out of specification.However, per bd juncos internal procedure finish point length measurement is a reference length, which means that finish point length is not a critical specification and does not impact the quality or function of the product if the required dimensions are within spec.Conclusion(s): bd juncos confirmed customer indicated failure mode although specification is not a release criteria.Bd juncos will send to bd supplier columbus a quality alert to request investigation for cannula 17ga 3-1/2in.No formal corrective action is required.
 
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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 Key7602262
MDR Text Key111663211
Report Number2618282-2018-00023
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,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
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
Date Manufacturer Received05/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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