MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problems Contamination (1120); Material Discolored (1170)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: discoloration / variation in color / cloudy.Patient problem code: f27 - no patient involvement.

Event Description

The department of urology of our hospital reported that a patient came to our hospital for treatment due to ureteral stones.After the patient's infusion, the nurse planned to use a prefilled catheter irrigator to flush and seal the indwelling needle.After opening the cap, it was found that the irrigator connector was stained and was not used.She replaced it with another one.A catheter irrigator is used.This irrigator contains sterile, non-pyrogenic and preservative-free 0.9% ns, which poses serious safety risks when performing aseptic operations.

Event Description

No additional information.The department of urology of our hospital reported that a patient came to our hospital for treatment due to ureteral stones.After the patient's infusion, the nurse planned to use a prefilled catheter irrigator to flush and seal the indwelling needle.After opening the cap, it was found that the irrigator connector was stained and was not used.She replaced it with another one.A catheter irrigator is used.This irrigator contains sterile, non-pyrogenic and preservative-free 0.9% ns, which poses serious safety risks when performing aseptic operations.

Manufacturer Narrative

(b)(4) - follow up mdr for correction and device evaluation.Correction: annex a code updated from a0407 - material discolored to a1801 - contamination.Device evaluation: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3117582.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SYRINGE 5ML 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17877888
• MDR Text Key: 325006778
• Report Number: 1911916-2023-00738
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065944
• UDI-Public: (01)30382903065944
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306594
• Device Lot Number: 3117582
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1