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

Catalog Number 306547

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Material #: 306547 batch#: 3090897 it was reported by customer that upon verification of hd catheter patency the nursing staff experienced a blood spray from inside the syringe (leaking around plunger).The patient was also soiled with blood.Questionable contamination of blood? blood not returned to patient.No patient harm verbatim: complaint received via email(s) attached.Upon verification of hd catheter patency the nursing staff experienced a blood spray from inside the syringe (leaking around plunger).The patient was also soiled with blood.Questionable contamination of blood? blood not returned to patient.

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.H3 other text : see h10 manufacture narrative.

Manufacturer Narrative

Pr (b)(4) follow up it was reported, upon verification of hemodialysis catheter patency, the nursing staff experienced a blood spray from inside the syringe.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a syringe filled with approximately 3.5ml of blood.There are drops of blood over the syringe rubber stopper.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.The prefilled syringe is designed to push the plunger rod-rubber stopper down until the saline solution has been expelled.After, the unit should be discarded.The product is not designed to continue use by pulling the plunger rod-rubber stopper back to aspirate blood or any other solution.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 3090897.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.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

Event Description

No additional information received material #: 306547 batch#: 3090897 it was reported by customer that upon verification of hd catheter patency the nursing staff experienced a blood spray from inside the syringe (leaking around plunger).The patient was also soiled with blood.Questionable contamination of blood? blood not returned to patient.Verbatim: complaint received via email(s) attached.Upon verification of hd catheter patency the nursing staff experienced a blood spray from inside the syringe (leaking around plunger).The patient was also soiled with blood.Questionable contamination of blood? blood not returned to patient.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALI NE 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: 18632762
• MDR Text Key: 334618310
• Report Number: 1911916-2024-00052
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• 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: 02/08/2024
• 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: 3090897
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1