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

Catalog Number 306594

Device Problem Material Deformation (2976)

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

Event Date 07/25/2023

Event Type  malfunction  

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 that the bd posiflush¿ syringe was found damaged/deformed when removed from the packaging.The following information was provided by the initial reporter, translated from chinese: "the patient underwent intrauterine adhesion in our hospital for infusion treatment, followed the doctor's advice to give fluid infusion, used a 5ml prefilled catheter irrigator to flush the infusion line before infusion, opened the prefilled catheter irrigator device and found that the instrument bolus was deformed and could not be used, so he had to replace the prefilled irrigator for infusion.".

Manufacturer Narrative

(b)(4) follow up mdr for device evaluation.A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 2108404.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

The patient underwent intrauterine adhesion in our hospital for infusion treatment, followed the doctor's advice to give fluid infusion, used a 5ml prefilled catheter irrigator to flush the infusion line before infusion, opened the prefilled catheter irrigator device and found that the instrument bolus was deformed and could not be used, so he had to replace the prefilled irrigator for infusion.

• Brand Name: BD POSIFLUSH¿ 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17926478
• MDR Text Key: 325843028
• Report Number: 1911916-2023-00766
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065944
• UDI-Public: (01)30382903065944
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: Other
• Device Catalogue Number: 306594
• Device Lot Number: 2108404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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