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

Catalog Number 306546

Device Problem Component Incompatible (1108)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the syringe pump kept producing an occlusion alarm while using the bd posiflush¿ normal saline syringe for the flush.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we¿ve received a few complaints from our clinical teams regarding the bd sodium chloride syringes reference number (b)(4) lot number 3016501 not working on medfusion devices.Pct informed of finding.9th floor noticed same finding on the night of 4/15 and information was shared house wide via house supervisor.As reported at the saturday huddle and the monday morning tier 2 huddle, some of the 9th floor nurses were unable to infuse flushes on the medfusion pumps.They kept getting an occlusion warning on the pump, but the lines were not occluded.At first, it was not clear if it was a pump issue or supply issue.Our charge nurse, did some investigation and discovered that it was a specific lot number of flushes that were the issue.She said that she pulled that lot number stock from our supply.Since that was done, i have not heard of any further issues.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: it was reported the sodium chloride syringes were not working on medfusion devices.To aid in the investigation, four hundred samples in sealed packaging flow wraps were received for evaluation by our quality team.Fifty samples were randomly selected for evaluation.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, per it287 and all results were within specification.It could be possible the customer is not using the product as intended.This product is not specified as pump compatible.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional product options.A device history record review was completed for provided material number 306546, lot 3016501.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 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16930651
• MDR Text Key: 315590901
• Report Number: 1911916-2023-00304
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 3016501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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