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 01/23/2024

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.

Event Description

Material #: 306547.Batch#: 3090897.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).".

Manufacturer Narrative

Updated event date 23-jan-2024.

Event Description

Material #: 306547, batch#: 3090897, 3333571, 3271933.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 miramichi new-brunswick.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 happen 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

Material #: 306547.Batch#: 3090897, 3333571, 3271933.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 miramichi new-brunswick.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.

Manufacturer Narrative

Pr (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 performed.It could be possible the customer is not using the product as intended.This product is single use and is not designed to pull the plunger rod back.After the saline solution has been expelled the syringe should be discarded.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional product options.A device history record review was completed for provided material number 306547, lot 3271933.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 no sample analysis the symptom reported by the customer could not be 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: 18760322
• MDR Text Key: 336415503
• Report Number: 1911916-2024-00138
• 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,Followup
• Report Date: 03/20/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 3271933
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1