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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DISCARDITII 2ML SYRG SYRINGE

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BECTON DICKINSON DISCARDITII 2ML SYRG SYRINGE Back to Search Results
Catalog Number 300849
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter addr 1: (b)(6). Investigation summary: no samples (including photos) were returned for the reported issue of ¿in one pack syringe marking of 1 ml is not shown properly. In some syringe marking it has become light and become black when we touch and slightly rub on marking¿ with lot number 1129916 regarding item # 300849, so retention samples were used for the investigation. The dhr of material number 300849 and lot number 1129916 was checked and no quality notification was recorded on this lot. No retention samples showed marking defect. The defect cannot be confirmed. The defect was simulated on the machine and on investigation it was found that this is mostly because of the toggle arm and bush was worn out and was overlooked during pm. As an action point for corrective and preventive action we have now been added the pm checklist to avoid overlooking and missing them on checking them out during preventive maintenance of the machine. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Based on the above, no additional investigation and no capa is required at this time. Investigation conclusion: no samples and no photographs were received from the customer and were used for investigation of the reported defects. The investigating team has used the retention samples of material code 300849 and lot number 1129916 for investigating the reported defect. No retention sample showed marking defect. The defect cannot be confirmed. The defect was simulated on the machine and on investigation it was found that this is majorly because of the toggle arm and bush worn out and got overlooked during pm as an action point for corrective and preventive action we have now been added the pm checklist to avoid overlooking and missing them on checking them out during preventive maintenance of the machine. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation.
 
Event Description
It was reported that the discarditii 2ml syrg experienced scale marking issues. The following information was provided by the initial reporter: syringe marking is become light and hand become black when when we touch and slightly rub on marking. In one pack syringe marking of 1 ml is not shown properly. In some syringe marking is become light and hand become black when when we touch and slightly rub on marking.
 
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Brand NameDISCARDITII 2ML SYRG
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12557166
MDR Text Key274250400
Report Number2243072-2021-02423
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300849
Device Lot Number1129916
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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