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

Catalog Number 306593

Device Problem Leak/Splash (1354)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (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.H3 other text : see h10 manufacture narrative.

Event Description

The patient was admitted to the hospital with a fractured femur, and on (b)(6) 2024 the nurse in charge followed the doctor's orders to seal the patient's indwelling needle after intravenous infusion, and when checking the packaging, she found that the prefilled catheter flusher was leaking from the packaging and was unusable, and she immediately replaced it with a different prefilled catheter flusher, which did not cause any harm to the patient.

Manufacturer Narrative

Pr (b)(4) follow up it was reported the prefilled catheter flusher was leaking.As a sample was not returned, a thorough sample evaluation could not be completed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a prefilled syringe in its packaging flow wrap.From the photos, it is not possible to observe the symptom reported by the customer.A device history record review was completed for provided material number 306593, lot 2209338.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

Event Description

No additional information received the patient was admitted to the hospital with a fractured femur, and on (b)(6) 2024 the nurse in charge followed the doctor's orders to seal the patient's indwelling needle after intravenous infusion, and when checking the packaging, she found that the prefilled catheter flusher was leaking from the packaging and was unusable, and she immediately replaced it with a different prefilled catheter flusher, which did not cause any harm to the patient.

• 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 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: 18650065
• MDR Text Key: 334653522
• Report Number: 1911916-2024-00057
• 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: 02/06/2024
• 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: 2209338
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1