MAUDE Adverse Event Report: BECTON DICKINSON SYR 10ML PUMP COMPATIBLE SALINE 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 03/27/2024

Event Type  malfunction  

Event Description

No additional information received material# 306547 batch# 3271934 it was reported by customer that the barrel of the syringe began to fill with blood and leak around the seal on the barrel and up the plunger.Verbatim: rcc received a complaint via email.Email(s) attached.Product: 306575 lot: 3271934 date of incident: (b)(6) 2024 patient harm: no issue: staff member attached 0.9% prefilled saline syringe 10ml to patient's cvc lumen/tego to access lumen by pulling on plunger of syringe to withdraw blood from cvc lumen.The barrel of the syringe began to fill with blood and leak around the seal on the barrel and up the plunger.Staff stopped using this same syringe and set it aside for examination and used several other 0.9% prefilled saline syringes without this same issue happening again.

Manufacturer Narrative

Pr (b)(4) follow up for device evaluation it was reported there was a leak around the seal on the barrel and up the plunger.To aid in the investigation, one empty syringe with no packaging flow wrap or tip cap was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.It could be possible the customer is not using the product as intended.The syringe is designed to push the plunger rod down to expel the solution and then be disposed of.The syringe is not designed to pull the plunger rod back.A device history record review was completed for provided material number 306547, lot 3271934.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 returned sample analysis the symptom reported by the customer could not be confirmed.

Manufacturer Narrative

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# 306575.Batch# 3271934.It was reported by customer that the barrel of the syringe began to fill with blood and leak around the seal on the barrel and up the plunger.Verbatim: rcc received a complaint via email.Email(s) attached.Product: 306575.Lot: 3271934.Date of incident: march 27, 2024.Patient harm: no.Issue: staff member attached 0.9% prefilled saline syringe 10ml to patient's cvc lumen/tego to access lumen by pulling on plunger of syringe to withdraw blood from cvc lumen.The barrel of the syringe began to fill with blood and leak around the seal on the barrel and up the plunger.Staff stopped using this same syringe and set it aside for examination and used several other 0.9% prefilled saline syringes without this same issue happening again.

• 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: 19117465
• MDR Text Key: 340678690
• Report Number: 3002682307-2024-00078
• 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: 04/19/2024
• 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: 3271934
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2024
• 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