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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NEEDLE 32X4 LA 5B; INSULIN SYRINGE
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BECTON DICKINSON AND CO. PEN NEEDLE 32X4 LA 5B; INSULIN SYRINGE Back to Search Results
Catalog Number 320478
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Pain (1994); Swelling (2091); Skin Tears (2516)
Event Date 05/31/2019
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 tearing of the skin occurred during use with a pen needle 32x4 la 5b.The following information was provided by the initial reporter, "the problem is that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.".
 
Event Description
It was reported that tearing of the skin occurred during use with a pen needle 32x4 la 5b.The following information was provided by the initial reporter, "the problem is that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.".
 
Manufacturer Narrative
Investigation summary: customer returned photos of the shelf carton of 4mm, 32g pen needles from lot # 8045594.Customer states that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.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.Based on the samples and/or photo(s) received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as the photos do not show the pen needles in question.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.Based on the above, no additional investigation and no capa is required at this time.
 
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Brand Name
PEN NEEDLE 32X4 LA 5B
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
MDR Report Key8727122
MDR Text Key150272379
Report Number9616656-2019-00553
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903204786
UDI-Public382903204786
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2023
Device Catalogue Number320478
Device Lot Number8045594
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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