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 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer 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.There was no report of patient impact.The following information was provided by the initial reporter: all 3 instances were on different patients.There were more than 3 instances prior to being notified of the issue and once it was identified, we removed that lot number and haven¿t had any issues since.The device was being used both on pump and manually.When the pump would alarm, we would try to flush by hand and it did not move and were unable to manually manipulate the syringe without extreme pressure being applied and re breaking the seal.These syringes were the prefilled normal saline syringes i have attached a picture of the 3 syringes that i was able to get a handle on.It does not show the issue but shows the same lot # and all.

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: all 3 instances were on different patients.There were more than 3 instances prior to being notified of the issue and once it was identified, we removed that lot number and haven¿t had any issues since.The device was being used both on pump and manually.When the pump would alarm, we would try to flush by hand and it did not move and were unable to manually manipulate the syringe without extreme pressure being applied and re breaking the seal.These syringes were the prefilled normal saline syringes i have attached a picture of the 3 syringes that i was able to get a handle on.It does not show the issue but shows the same lot # and all.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 18-oct-2023.H.6.Investigation summary: it was reported the device was being used both on a pump and manually.The customer was unable to manually manipulate the syringe without extreme pressure being applied.To aid in the investigation, thirty samples in sealed packaging flow wraps and one photo was 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, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.The photo provided shows three empty syringe with their syringe barrel label.No other information could be obtained from the photo.It could be possible the customer is not using the product as intended.Product 306546 is not specified for pump compatibility.A device history record review was completed for provided material number 306546, lot 3142760.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 17863521
• MDR Text Key: 324835697
• Report Number: 1911916-2023-00720
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3142760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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