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

Catalog Number 306546

Device Problem Material Separation (1562)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported whikle using the bd posiflush¿ normal saline syringe, stopper separated from the plunger.The following was received by the initial reporter.10ml posi -flush was attached to the patient post dialysis.Patient line was flushed easily.Upon aspirating, the 10ml posi-flush plunger separated from the stopper in the syringe.No harm to patient.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using the bd posiflush¿ normal saline syringe, stopper separated from the plunger.The following was received by the initial reporter.10ml posi -flush was attached to the patient post dialysis.Patient line was flushed easily.Upon aspirating, the 10ml posi-flush plunger separated from the stopper in the syringe.No harm to patient.

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: 13-oct-2023 h.6.Investigation summary: it was reported, upon aspirating, the plunger separated from the stopper in the syringe.To aid in the investigation, two samples and two photos were received for evaluation by our quality team.One sample is an empty syringe, and the other sample has solution.A visual inspection was performed, and no defects or imperfections were observed.The two photos provided show syringes in a plastic bag.No other information could be obtained from the photos.It could be possible the customer is not using the product as intended.The flush syringes are designed to press the plunger rod down to expel the solution.After the solution is expelled, the unit needs to be discarded.The unit is not designed for aspiration.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 (b)(4), lot 3142754.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.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.H3 other text : see h10.

• 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 Key: 17901547
• MDR Text Key: 325466384
• Report Number: 1911916-2023-00752
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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 Number: 306546
• Device Lot Number: 3142754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA 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