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

Catalog Number 306593

Device Problem Component Missing (2306)

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

Event Date 02/01/2024

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

The patient was admitted to the hospital for prostatic hyperplasia, and on (b)(6) 2024, the charge nurse treated the patient with intravenous fluids as prescribed by the physician, and at the end of the procedure, when using a prefilled catheter flosser for indwelling needle sealing, he found that the prefilled catheter flosser did not have a tapered head cap and was unusable, and he was immediately replaced without causing harm to the patient.

Manufacturer Narrative

(b)(4) follow up.It was reported the prefilled catheter flosser did not have a tapered head cap and was unusable.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe with no packaging flow wrap or tip cap.No other information could be obtained from the photo.A device history record review was completed for provided material number 306592, lot 2096923.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 is confirmed, but 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 for prostatic hyperplasia, and on (b)(6) 2024, the charge nurse treated the patient with intravenous fluids as prescribed by the physician, and at the end of the procedure, when using a prefilled catheter flosser for indwelling needle sealing, he found that the prefilled catheter flosser did not have a tapered head cap and was unusable, and he was immediately replaced without causing 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: 18759504
• MDR Text Key: 336976971
• Report Number: 1911916-2024-00132
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065937
• UDI-Public: (01)30382903065937
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 2096923
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1