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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LL BNS PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 30ML LL BNS PISTON SYRINGE Back to Search Results
Catalog Number 301033
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter state: the state was determined by the provided area code. Investigation summary: a device history record review was completed by our quality engineer team for provided material number 301033 and lot number 1026744. The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification. As a sample was unavailable for return, a thorough sample investigation could not be completed. Based on the investigation results, an exact cause for this incident could not be identified. There are quality controls currently in place to detect this type of defect during the production process. Further action has not been determined necessary at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed. We will continue monitoring the complaint trend for this product and symptom. With no sample analysis a probable root cause could not be offered.
 
Event Description
It was reported that the syringe 30ml ll bns experienced device damage while still considered operable, and leakage. The following information was provided by the initial reporter: i sent the questions to the customer and this is the only reply i received. We actually had two syringes in a row out of two kits crack. I apologized they have both been disposed of.
 
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Brand NameSYRINGE 30ML LL BNS
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12543731
MDR Text Key273772915
Report Number1911916-2021-01030
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
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
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301033
Device Lot Number1026744
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2021
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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