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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE INSULIN 1ML 30GA INSULIN SYRINGE

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BECTON DICKINSON DE MEXICO SYRINGE INSULIN 1ML 30GA INSULIN SYRINGE Back to Search Results
Catalog Number 326780
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems Pain (1994); Loss of consciousness (2418)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter name and address: (b)(6). 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 syringe insulin 1ml 30ga experienced foreign matter in the fluid path. The lay user/patient received medication as a result of the incident. The following information was provided by the initial reporter: a customer bought a pack of ¿bd ultra-fine 1 ml¿ syringes (sku 14729) and within hours he returned upset, indicating that the syringes were open, representing a health hazard for the user. At the scene he requested to open another box and together with the pharmacy manager they realized that even though the box was closed and sealed, the inside of the bag was open. The patient, uses insulin syringes, wants to make a claim and report, because the product was already used. He indicated that after making use of the same that he bought in a pharmacy, he presented general discomfort, such as pain, loss of consciousness. Later, he realized that the syringes were used and fears that he is infected. When they went back to the pharmacy where they had purchased this product, they confirmed that there were other syringes in the same condition. I felt bad. It was a horrible discomfort, headache and spinal cord that left me lying on the floor approximately 1 hour, as soon as i recovered i proceeded to inspect the box to realize that some were contaminated without a needle and others with black residue inside them, probably rotten blood.
 
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Brand NameSYRINGE INSULIN 1ML 30GA
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12479170
MDR Text Key271635729
Report Number9614033-2021-00107
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326780
Device Lot Number1088884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/16/2021 Patient Sequence Number: 1
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