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

Catalog Number 306547

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Material# 306547.Lot 3271895.It was reported by the customer "that there was blood leakage with 3 syringes, in one incident the plugger was pulled and blood came out from the side of the plugger and splashed the nurse glove, while when the plugger was pushed to expel the saline, blood came out on the side of the plugger in two incidents.Verbatim: we just had 3 more incidents this morning, it happened during the flushing of the hemodialysis catheter.One incident happened will the plugger was pulled and blood came out from the side of the plugger and splashed the nurse glove.The 2 others happened when the plugger was pushed to expel the saline, blood came out on the side of the plugger.It did involve the patient and staff.I¿m sending you the pictures with the lot numbers.

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

No additional information received.Material# 306547 lot 3271895.It was reported by the customer "that there was blood leakage with 3 syringes, in one incident the plugger was pulled and blood came out from the side of the plugger and splashed the nurse glove, while when the plugger was pushed to expel the saline, blood came out on the side of the plugger in two incidents.Verbatim: we just had 3 more incidents this morning, it happened during the flushing of the hemodialysis catheter.One incident happened will the plugger was pulled and blood came out from the side of the plugger and splashed the nurse glove.The 2 others happened when the plugger was pushed to expel the saline, blood came out on the side of the plugger.It did involve the patient and staff.I¿m sending you the pictures with the lot numbers.

Manufacturer Narrative

(b)(4)follow up it was reported there was blood leakage with syringes.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows an empty syringe with the rubber stopper-plunger rod all the way down.It is upside down and there is a red solution that is past the rubber stopper.The second photo shows two empty syringes with the rubber stopper-plunger rod all the way down.Both of these syringes have a red solution between the rubber stopper ribs.No other defects or imperfections were observed.This product is not designed to pull the plunger rod back.Pulling back on the plunger rod either before, during or after the administration of the saline flush may lead to leakage past the stopper.A device history record review was completed for provided material number 306547, lot 3271895.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 photo sample analysis the symptom reported by the customer is confirmed.

• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18806815
• MDR Text Key: 337626241
• Report Number: 1911916-2024-00151
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024
• 2 Devices were Involved in the Event: 1 2

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: 306547
• Device Lot Number: 3271895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1