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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306575
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
It was reported that bd posiflush¿ pre-filled saline syringe had a difficult to move plunger.The following information was provided by the initial reporter: "malfunction of 10 ml, pre-filled normal saline syringe.Writer was flushing cvc lumen with syringe when is suddenly stopped with approximately 4.5 ml remaining in syringe.".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter zip code: (b)(6).
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter zip code: (b)(6).
 
Event Description
It was reported that bd posiflush¿ pre-filled saline syringe had a difficult to move plunger.The following information was provided by the initial reporter: "malfunction of 10 ml, pre-filled normal saline syringe.Writer was flushing cvc lumen with syringe when is suddenly stopped with approximately 4.5 ml remaining in syringe.".
 
Manufacturer Narrative
H6: investigation: it was reported the syringe suddenly stopped while flushing.To aid in the investigation, one sample with no packaging flow wrap was received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the result was within specification.It could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number 306575, lot number 1169108.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
 
Event Description
It was reported that bd posiflush¿ pre-filled saline syringe had a difficult to move plunger.The following information was provided by the initial reporter: "malfunction of 10 ml, pre-filled normal saline syringe.Writer was flushing cvc lumen with syringe when is suddenly stopped with approximately 4.5 ml remaining in syringe.".
 
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Brand Name
BD POSIFLUSH¿ 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12925430
MDR Text Key285649266
Report Number1911916-2021-01212
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCA
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 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306575
Device Lot Number1169108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2021
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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