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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN.; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN.; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE Back to Search Results
Catalog Number 305180
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 305180 and lot number 2245213.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.
 
Event Description
It was reported that the bd¿ blunt fill needle 18 g x 1 1/2 in.Experienced black particle debris inside the edge of the red product container, sealed inside the sterile packaging.The following information was provided by the initial reporter: black particulate debris found inside the edge of the red product container, sealed inside the sterile packaging.
 
Event Description
It was reported that the bd¿ blunt fill needle 18 g x 1 1/2 in.Experienced black particle debris inside the edge of the red product container, sealed inside the sterile packaging.The following information was provided by the initial reporter: black particulate debris found inside the edge of the red product container, sealed inside the sterile packaging.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 305180 and lot number 2245213.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.H3 other text : see h10.
 
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Brand Name
BD¿ BLUNT FILL NEEDLE 18 G X 1 1/2 IN.
Type of Device
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16274671
MDR Text Key309062633
Report Number1911916-2023-00046
Device Sequence Number1
Product Code GAA
UDI-Device Identifier00382903051809
UDI-Public00382903051809
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305180
Device Lot Number2245213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2023
Initial Date FDA Received01/31/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received05/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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