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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306546
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2023
Event Type  malfunction  
Event Description
It was reported while using bd posiflush¿ normal saline syringes, the stopper separated from the plunger.There was no report of patient impact.The following information was provided by the initial reporter: we have noticed some of the saline flushes, both sterile and non-sterile, that have loose plungers and are coming apart when aspirating central lines.Below is what clinical team described of the issue.Multiple bd syringes (sterile and unsterile) seem to have loose plungers that disconnect from the black rubber part inside the syringe when aspirating our central lines.These are normally screwed in place and it seems they have been manufactured loosely and are coming apart.
 
Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-may-2023.It was reported plungers disconnect from the black rubber part inside the syringe when aspirating.To aid in the investigation, one sample with no packaging flow wrap, tip cap, or plunger was received for evaluation by our quality team.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed, including with the rubber stopper.The syringe barrel has a retaining ring 1/8" from the top that prevents the plunger rod from breaking out of the syringe barrel.No damages were observed to the retaining ring.It could be possible the customer is not using the product as intended.This product is designed to push down the plunger rod to expel the solution while flushing the iv line.It is not designed for other uses.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional training or product options.A device history record review was completed for provided material number 306546, lot 2241154.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.H3 other text : see h10.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringes, the stopper separated from the plunger.There was no report of patient impact.The following information was provided by the initial reporter: we have noticed some of the saline flushes, both sterile and non-sterile, that have loose plungers and are coming apart when aspirating central lines.Below is what clinical team described of the issue.Multiple bd syringes (sterile and unsterile) seem to have loose plungers that disconnect from the black rubber part inside the syringe when aspirating our central lines.These are normally screwed in place and it seems they have been manufactured loosely and are coming apart.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16797490
MDR Text Key313847904
Report Number1911916-2023-00250
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065462
UDI-Public(01)00382903065462
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003553
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 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306546
Device Lot Number2241154
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2022
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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