MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

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.

Event Description

It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.This occurred 480 times.There was no report of patient impact.The following information was provided by the initial reporter: issue started last week not sure of the exact date but could of been thursday or friday.Customer states they use them to flush blood out of catheters, state that they are sticking and they are pushing so hard to push the saline out that they are afraid damaging patient's veins from all the pressure or having to remove and replace catheters.They want to avoid that and do not feel comfortable using the product but they are using it until they can get some replacements from their supplier.The plunger is hard to push but there appears to be a sticking point but once they are able to get pass that then they can use it but they have to use a lot of pressure and they feel the lot is faulty.Mat # 306546.Lot 3072507.Issue has occurred with around 45ea.They do not have samples of the actual product to send back that has had the issue.They do have representative samples to send in.They do not have any photos of the product that the issue has occurred with.

Event Description

It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.This occurred 480 times.There was no report of patient impact.The following information was provided by the initial reporter: issue started last week not sure of the exact date but could of been thursday or friday.Customer states they use them to flush blood out of catheters, state that they are sticking and they are pushing so hard to push the saline out that they are afraid damaging patient's veins from all the pressure or having to remove and replace catheters.They want to avoid that and do not feel comfortable using the product but they are using it until they can get some replacements from their supplier.The plunger is hard to push but there appears to be a sticking point but once they are able to get pass that then they can use it but they have to use a lot of pressure and they feel the lot is faulty.Mat # 306546, lot 3072507.Issue has occurred with around 45ea.They do not have samples of the actual product to send back that has had the issue.They do have representative samples to send in.They do not have any photos of the product that the issue has occurred with.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-sep-2023 h6: investigation summary it was reported the flushes are sticking.To aid in the investigation, two samples in sealed packaging flow wraps were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.A device history record review was completed for provided material number (b)(4), lot 3072507.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.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 determined.H3 other text : see h10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17786502
• MDR Text Key: 323907430
• Report Number: 1911916-2023-00678
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• 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: 09/25/2023

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: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3072507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1