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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Device problem code: a0413 - material separation.Patient problem code: f26 ¿ no health consequences or impact.

Event Description

Morning infusion, the needle plug separated from the piston during cvc retraction with a 10 ml catheter flosser, resulting in retraction failure.

Event Description

(b)(4).- no additional information received.Morning infusion, the needle plug separated from the piston during cvc retraction with a 10 ml catheter flosser, resulting in retraction failure.

Manufacturer Narrative

(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2283679.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.It could be possible the customer is not using the product as intended.This product is designed to push the plunger rod down and dispose it.It is not designed to pull the plunger rod back.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.

• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18208700
• MDR Text Key: 328996205
• Report Number: 1911916-2023-00858
• 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: K003553
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• 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: 2283679
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO