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

Catalog Number 306595

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/05/2023

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.

Event Description

Reported by nurse manager, foreign substance found in product prior to use, number of units affected 1, green claim required, photos available, sample can be returned, complaint response letter not required, complaint receipt letter not required.

Manufacturer Narrative

Pr 9344530 follow up.It was reported a foreign substance was found in the product prior to use.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 syringe with no packaging flow wrap.It appears there is foreign matter at the bottom of the syringe.No other information could be obtained from the photos.A device history record review was completed for provided material number 306595, lot 2347133.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 sample analysis the symptom reported by the customer is confirmed, but without the actual sample analysis a probable root cause could not be offered.

Event Description

No additional information received.Reported by nurse manager, foreign substance found in product prior to use, number of units affected 1, green claim required, photos available, sample can be returned, complaint response letter not required, complaint receipt letter not required.

• 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: 18365786
• MDR Text Key: 331007609
• Report Number: 1911916-2023-00906
• 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: 01/23/2024

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: 2347133
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/23/2024
• 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