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

Model Number 306546

Device Problem Defective Component (2292)

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

Event Date 03/29/2023

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 stopper did not properly disengage.There was no report of patient impact.The following information was provided by the initial reporter: while performing push-pull per protocol on pt iv.Ns flush plunger failed to disengage from syringe.Pt was not harmed, replaced with new ns flush and pt care was provided appropriately.

Manufacturer Narrative

H6: investigation summary it was reported, while performing the push-pull per protocol on the patient's iv, the flush plunger failed to disengage from the syringe.As a sample was not returned, a thorough sample investigation could not be completed.It could be possible the customer is not using the product as intended.This product is designed to flush the iv line by pushing the plunger rod down.After, the syringe should be disposed.It is not designed for pulling the plunger rod back.A device history record review was completed for provided material number 306546, lot 2178295.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 no sample analysis the symptom reported by the customer could not be confirmed.

Event Description

It was reported while using bd posiflush¿ normal saline syringes, the stopper did not properly disengage.There was no report of patient impact.The following information was provided by the initial reporter: while performing push-pull per protocol on pt iv.Ns flush plunger failed to disengage from syringe.Pt was not harmed, replaced with new ns flush and pt care was provided appropriately.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16757424
• MDR Text Key: 313814509
• Report Number: 1911916-2023-00244
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 2178295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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