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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 SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306547
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2023
Event Type  malfunction  
Event Description
It was reported while using the bd posiflush¿ normal saline syringe the plunger was difficult to move.The following was received from the initial reporter: customer seem to have certain lot number of prefilled flush syringes that the plunger is somewhat ¿stuck¿ to the barrel.It takes a fair amount of pressure to dislodge the plunger causing fluid to squirt from the syringe.
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, 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: 11-oct-2023.H6: investigation summary: it was reported the plunger is stuck to the barrel.To aid in the investigation, one empty sample with no packaging flow wrap or tip cap 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.A device history record review was completed for provided material number 306547, lot 3207548.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.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be determined.
 
Event Description
It was reported while using the bd posiflush¿ normal saline syringe the plunger was difficult to move.The following was received from the initial reporter: customer seem to have certain lot number of prefilled flush syringes that the plunger is somewhat ¿stuck¿ to the barrel.It takes a fair amount of pressure to dislodge the plunger causing fluid to squirt from the syringe.
 
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Brand Name
BD POSIFLUSH¿ NORMAL 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 Key17873142
MDR Text Key324976073
Report Number1911916-2023-00731
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065470
UDI-Public(01)30382903065470
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/12/2023
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 Health Professional
Device Catalogue Number306547
Device Lot Number3207548
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2023
Initial Date FDA Received10/04/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2023
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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