MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Defective Component (2292)

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

Event Date 03/01/2024

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

Material: 306547 , lot: unknown.It was reported by the customer that when doing catheter irrigation with back-and-forth motion to check permeability, no resistance noted during the incident.Verbatim: additional information received on 01-mar-2024 with this additional occurrence.Which is the affected lot number of this complaint? 198368 but now happening also with all different number.Staff are aware to report any issue and i am receiving more feedback from the staff.We cannot look at only one lot number anymore when did the incident occur? february 28.Receive another one today date of event.Was there any patient involvement? yes was there any adverse event or serious injury reported? no.Any adverse event or serious injury reported to patient or healthcare professional? no.Any physical sample or photo available for investigation? send picture with incident report don¿t have it anymore if yes, are you able to provide the address of the facility for us to ship the return label? i have a sample of another lot number.See the address in my signature any picture of this complaint? no.Can you please provide more details and describe how the product is damaged.We are doing catheter irrigation with back and forth motion to check permeability.No resistance noted during the incident.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19006001
• MDR Text Key: 339085446
• Report Number: 1911916-2024-00223
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1