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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD ULTRA FINE PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320122
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 lot# on the box of bd ultra fine¿ pen needles was 0043788, but the lot# on the needle labels was 0231156.The following information was provided by the initial reporter: "he also reported that the lot number on the needles inside of the box is different from the lot number on the box." "the lot # from the box is 0043788 and the lot # on the needles is 0231156.".
 
Event Description
It was reported that the lot# on the box of bd ultra fine¿ pen needles was 0043788, but the lot# on the needle labels was 0231156.The following information was provided by the initial reporter: "he also reported that the lot number on the needles inside of the box is different from the lot number on the box." "the lot # from the box is 0043788 and the lot # on the needles is 0231156.".
 
Manufacturer Narrative
H6: investigation summary customer returned a total of twelve 4mm, 32 gauge nano pro pen needles from lot 0231156.No standard nano samples from lot 0043788 were returned.The returned samples were inspected to ensure that using them was as least harmful as intended.The outer diameters of these needles were measured, the results of which are featured below: 1.0.0093 in 2.0.0094 in 3.0.0093 in 4.0.0094 in 5.0.0093 in 6.0.0092 in 7.0.0093 in 8.0.0094 in 9.0.0093 in 10.0.0092 in 11.0.0093 in 12.0.0094 in all of the needles were measured within acceptable outer diameters for 32 gauge needles (0.0090 in to 0.0095 in).The integrity of each needle point was inspected and no defects were found.No debris was found at the tip of any of the needles.Lastly, flour was applied to the needles¿ cannulas to ensure that lubricant was present.Sufficient lubricant was found on all samples.The only damage to the needles were some signs of use.The needles did not feature any dullness or burrs.The shelf carton associated with these teardrops was not returned, so no investigation into the reported discrepancy between the lot number on the shelf carton and the teardrop labels on the pen needles could be made.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 as per the applicable operations and met qc specifications.Since the samples received for this record are not from the reported catalogue and lot number, bd was unable to confirm the customer¿s indicated failure of needle pain during use.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
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Brand Name
BD ULTRA FINE PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
MDR Report Key12143637
MDR Text Key261143922
Report Number9616656-2021-00795
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903201228
UDI-Public00382903201228
Combination Product (y/n)N
PMA/PMN Number
K162516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number320122
Device Catalogue Number320122
Device Lot Number0043788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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