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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
Model Number 306546
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2023
Event Type  malfunction  
Event Description
It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: the customer complained that the plunger of the syringe was stuck in the middle.It was very hard to push.
 
Manufacturer Narrative
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, returned to manufacturer on: 28-mar-2023.H6: investigation summary: it was reported the plunger of the syringe was stuck in the middle and was very hard to push.To aid in the investigation, one empty sample with no packaging blister or tip cap, and three photos were provided 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, per it287 and the result was within specification.The three photos provided show the sample received.A device history record review was completed for provided material number 306546, lot 2286205.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 issues.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.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 offered.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: the customer complained that the plunger of the syringe was stuck in the middle.It was very hard to push.
 
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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 Key16570350
MDR Text Key311572991
Report Number1911916-2023-00157
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public(01)30382903065463
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K003553
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 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number306546
Device Catalogue Number306546
Device Lot Number2286205
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2022
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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