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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306595
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2023
Event Type  malfunction  
Manufacturer Narrative
H3.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 bd pre-filled saline syringe tip is damaged.The following information was provided by the initial reporter, translated from chinese to english: use the flush to flush the catheter before infusion and found that the front knob is damaged.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2168084.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.
 
Event Description
It was reported that the bd pre-filled saline syringe tip is damaged.The following information was provided by the initial reporter, translated from chinese to english: use the flush to flush the catheter before infusion and found that the front knob is damaged.
 
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Brand Name
BD PRE-FILLED SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17553617
MDR Text Key321803508
Report Number1911916-2023-00588
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306595
Device Lot Number2168084
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2022
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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