MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306595

Device Problem Leak/Splash (1354)

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

Event Date 01/15/2024

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 package was not opened and liquid leakage was found in the entire box.

Manufacturer Narrative

(b)(4) follow up.It was reported liquid leakage was found in the entire box.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, five photos were provided for evaluation by our quality team.Three of the photos show the flow wrap removed from an empty syringe and the plunger rod-rubber stopper out of the syringe.The other two photos show a packaging shelf box with wet marks from the saline of the emptied syringe.No other information could be obtained from the photo.The condition of the sample shown in the photos does not represent the condition of how the product leaves the manufacturing site.A device history record review was completed for provided material number 306595, lot 2347132.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 a probable root cause could not be determined.

Event Description

Additional information received: visual inspection and analysis should be because of the separation of the core rod and leakage, and it is the packaging seal that i personally opened, and the inside of the package is already separated, and the water stains on the outer packaging have dried, it should have been leaking for a long time.The package was not opened and liquid leakage was found in the entire box.

• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18554647
• MDR Text Key: 333388422
• Report Number: 1911916-2024-00030
• 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: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 2347132
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1