MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE 3ML FILL; SALINE VASCULAR ACCESS FLUSH

Model Number 306544

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

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was performed for provided lot number 203206.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, two photos were received for evaluation by our quality team.They show a syringe with pink color in the luer tip cap area.Investigation conclusion: based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed root cause description: without a physical sample available for investigation, a cause for the reported incident could not be determined.Rationale: 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.

Event Description

It was reported that a pink, foreign substance was found on the syringe 3ml saline 3ml fill hub.The following information was provided by the initial reporter: "pink substance on syringe hub".

• Brand Name: SYRINGE 3ML SALINE 3ML FILL
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11174418
• MDR Text Key: 227579319
• Report Number: 1911916-2021-00031
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 306544
• Device Catalogue Number: 306544
• Device Lot Number: 0203206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1