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

Catalog Number 306546

Device Problem Partial Blockage (1065)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

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 movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: plunger does not expel all of the saline in the syringe.Only about 3 ml of saline can be expelled from the syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-mar-2023.H6: investigation summary it was reported the plunger does not expel all of the saline in the syringe.To aid in the investigation, two empty samples with no packaging blister or tip cap were received for evaluation by our quality team.A visual inspection was performed, and no defect or imperfections were observed.Each 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 all results were within specification.A device history record review was completed for provided material number 306546, lot 2263069.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.H3 other text : see h10.

Event Description

It was reported while using bd posiflush¿ normal saline syringes, the plunger movement was difficult.There was no report of patient impact.The following information was provided by the initial reporter: plunger does not expel all of the saline in the syringe.Only about 3 ml of saline can be expelled from the syringe.

• 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: 16441169
• MDR Text Key: 310368138
• Report Number: 1911916-2023-00102
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306546
• Device Lot Number: 2263069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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