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 02/28/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe stopper separated from the plunger during use.The following information was provided by the initial reporter: "the plastic part of the plunger easily detached from the rubber stopper part of the plunger¿.Chemotherapy drug in contact with the syringes: vincristine".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that the bd posiflush¿ normal saline syringe stopper separated from the plunger during use.The following information was provided by the initial reporter: "the plastic part of the plunger easily detached from the rubber stopper part of the plunger.¿ chemotherapy drug in contact with the syringes: vincristine.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-may-2023.H6: investigation summary it was reported the customer is not able to push, and twice, not able to draw back the syringe, and the plastic part of the plunger easily detached from the rubber stopper.To aid in the investigation, two empty syringes with no packaging flow wraps were received 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 per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the results were within specification.It could be possible the customer is not using the product as intended.This product is designed to be pushed down while expelling the solution, not to pull the plunger rod-rubber stopper back.A device history record review was completed for provided material number 306546, lot 2234958.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.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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16572737
• MDR Text Key: 311672540
• Report Number: 1911916-2023-00158
• 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,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 2234958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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