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

Catalog Number 306595

Device Problem Fracture (1260)

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

Event Date 10/17/2023

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

At 9 o'clock on (b)(6) 2023, when the patient was connected to the drug and used the prefill, the prefilled tube was checked for a crack of one centimeter, and the patient was replaced with a new precharge for treatment, without causing harm to the patient.

Event Description

(b)(4) additional information at 9 o'clock on (b)(6) 2023, when the patient was connected to the drug and used the prefill, the prefilled tube was checked for a crack of one centimeter, and the patient was replaced with a new precharge for treatment, without causing harm to the patient.The pre-filling was used in the department, and the pre-filled tube body was checked to have a cm crack, which had been confirmed with the department, which may have been squeezed during transportation, and the patient was replaced with a new pre-filled for treatment in time, without causing harm to the patient, and no samples and photos were left.

Manufacturer Narrative

(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2258358.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• 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: 18401453
• MDR Text Key: 331497651
• Report Number: 1911916-2023-00923
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: 306595
• Device Lot Number: 2258358
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1