MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 30654778

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f24 - insufficient information.Device problem code: a050401 - fluid/blood leak.

Event Description

Mat#: 30654778.Lot#: unknown.It was reported by customer that blood shot outside back of plunger while infusing into a dialysis catheter.The same thing happened with both syringes.

Manufacturer Narrative

(b)(4).Follow up as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.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.H3 other text : see h10 narrative.

Event Description

No additional information received mat#: 30654778 lot#: unknown it was reported by customer that blood shot outside back of plunger while infusing into a dialysis catheter.The same thing happened with both syringes.Verbatim: rcc received a complaint via email.Email(s) attached.Blood shot outside back of plunger while infusing into a dialysis catheter.The same thing happened with both syringes.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• 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: 18094424
• MDR Text Key: 328625789
• Report Number: 1911916-2023-00831
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• 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,Followup
• Report Date: 11/10/2023

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: 30654778
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1