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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 3ML LL 200 S/C PISTON SYRINGE

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BECTON DICKINSON DE MEXICO SYRINGE 3ML LL 200 S/C PISTON SYRINGE Back to Search Results
Catalog Number 309657
Device Problems Mechanical Problem (1384); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2019
Event Type  malfunction  
Manufacturer Narrative
(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 3ml ll 200 s/c experienced a connectivity issue. The following information was provided by the initial reporter material no. 309657, batch no. 8222973. No additional information is available. Description of issue: customer reported syringe did not pull back on its own from cartridge. Customer tried different cartridge and different syringe. Customer suspects the needle may not screw on well to the syringe, customer not exactly sure what the issue is. Did the customer insert the needle into the cartridge and encounter fill resistance? no. Proceed to step 3. Number of occurrences: 1. Item number. Choose one: 3 ml syringe ¿ 309657, 26 g, 3/8¿ needle ¿ 305110. Product lot number: 8222973. Are samples available for investigation? yes. Does customer authorize bd to contact customer to obtain sample(s)? yes. Did issue cause any injury? if yes, what type of injury? no. Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no. Resolution: bd might follow up with customer regarding returning syringe/needle. No further distributor follow up is required. Customer used a different needle and completed load successfully without issues. Note: product category
=
needle/syringe issue.
 
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Brand NameSYRINGE 3ML LL 200 S/C
Type of DevicePISTON 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8615792
MDR Text Key159415152
Report Number9614033-2019-00151
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309657
Device Lot Number8222973
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2018
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: 05/16/2019 Patient Sequence Number: 1
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