MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306595

Device Problem Material Separation (1562)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

(b)(6) 2023.The child was treated in the general surgery department and required tube flushing between different medications.The prefilled catheter flusher was opened and found to have separated and dislodged the syringe's rubber movable stopper and push rod.This was immediately reported to the department head and another prefilled catheter flusher was used to flush the tube.There was no impact on the child.The manufacturer (corporate) unit was notified.Prefilled catheter flusher quality issues with the product were brought back to the manufacturer for investigation.

Manufacturer Narrative

Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2315325.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.H3 other text : see h10 narrative.

Event Description

No additional information received.(b)(6) 2023 the child was treated in the general surgery department and required tube flushing between different medications.The prefilled catheter flusher was opened and found to have separated and dislodged the syringe's rubber movable stopper and push rod.This was immediately reported to the department head and another prefilled catheter flusher was used to flush the tube.There was no impact on the child.The manufacturer (corporate) unit was notified.Prefilled catheter flusher quality issues with the product were brought back to the manufacturer for investigation.

• Brand Name: SYRINGE 10ML SALINE FILL CHINA SP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18329101
• MDR Text Key: 330576815
• Report Number: 1911916-2023-00893
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065951
• UDI-Public: (01)30382903065951
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306595
• Device Lot Number: 2315325
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1