MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306593

Device Problem Break (1069)

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

Event Date 01/12/2024

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

On 1.12, the patient was given an early premedication post-punch sealing tube treatment, and it was found that the handle of the instrument was damaged with sharp edges, which could easily cause injury to the operator.No harm.

Manufacturer Narrative

Pr (b)(4).- follow up mdr for correction.Following the submission of the initial mdr, it was determined that the customer's reported failure was not a reportable event to the fda as this failure is not likely to cause or contribute to serious injury or death.

Event Description

No additional information.

• Brand Name: SYRINGE 3ML 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 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: 18640451
• MDR Text Key: 334569945
• Report Number: 1911916-2024-00055
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306593
• Device Lot Number: 2096914
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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