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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Material #: 306547, batch#: 3333571.It was reported by customer that there was a blood splat outside the piston.Verbatim: "i have had another issue with a bd syringe.Here is a picture below and you can see the lot number.We use these syringes to irrigate our hemodialysis catheter.This problem happened in our satellite unit in (b)(6).During irrigation, there was a blood leak (if you can see in the picture there was a blood splat outside the piston)." additional information: those incident did happened on a daily basis, at lease twice daily.We now have the same issue with a different one.Lot number 3333571,ref (b)(4).Occurred during flush of the catheter, when pulling the plunger.

Event Description

No additional information received.  material #: 306547, batch#: 3333571.It was reported by customer that there was a blood splat outside the piston.Verbatim: "i have had another issue with a bd syringe.Here is a picture below and you can see the lot number.We use these syringes to irrigate our hemodialysis catheter.This problem happened in our satellite unit in (b)(6).During irrigation, there was a blood leak (if you can see in the picture there was a blood splat outside the piston)".Additional information: those incident did happened on a daily basis, at lease twice daily.We now have the same issue with a different one.Lot number 3333571,ref 306547.Occurred during flush of the catheter, when pulling the plunger.

Manufacturer Narrative

(b)(4) follow up, it was reported there was a blood splat outside the piston.As a sample was not returned, a thorough sample evaluation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows syringes with blood in them.One syringe had the plunger rod-rubber stopper all the way up with blood between the rubber stopper ribs.No other information could be obtained from the photo.It could be possible the customer is not using the product as intended.This product should be discarded after expelling the solution.It is not designed to pull the plunger rod-rubber stopper back.A device history record review was completed for provided material number 306547, lot 3333571.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.However, this is off label use.

• 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: 18884673
• MDR Text Key: 337660458
• Report Number: 1911916-2024-00171
• 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: 03/22/2024
• 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: 3333571
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1