MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Crack (1135)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f26 ¿ no health consequences or impact device problem code: a0404 - crack.

Event Description

Material#:306546 batch#: 3026607 it was reported by the customer that "i have a picc line for daily hydration with iv medications and ivig every 3 weeks.Today to flush my line, following my infusion, i connected a 10 ml bd posiflush¿ prefilled normal saline flush syringe.When i started to inject the saline, it sprayed everywhere.I immediately disconnected the syringe and found a longitudinal crack in the syringe.Without pressure the syringe does not leak.I hope the syringe contents were not contaminated and that none of the fluid contents actually entered my cvl catheter as a possible source of infection." verbatim: ¿ product name: bd posiflush¿ prefilled normal saline flush syringe, 10 ml syringe ¿ lot number: 3026607 ¿ any injuries and/or harm: possible risk that contaminated saline was injected into picc line creating a risk of infection.¿ what is the issue you experienced?: i have a picc line for daily hydration with iv medications and ivig every 3 weeks.Today to flush my line, following my infusion, i connected a 10 ml bd posiflush¿ prefilled normal saline flush syringe.When i started to inject the saline, it sprayed everywhere.I immediately disconnected the syringe and found a longitudinal crack in the syringe.Without pressure the syringe does not leak.I hope the syringe contents were not contaminated and that none of the fluid contents actually entered my cvl catheter as a possible source of infection.¿ is the actual sample or sample representative available? (if possible, please send affected sample): yes, i have the syringe.

Manufacturer Narrative

Material 306546, batch 3026607, ran on the sp1 line from the 1st to the 15th of february 2023.The non-conformances were reviewed for this batch, and there was one possible non-conformance which could contribute to the complaint verbatim reported by the customer.However, as there was no physical sample available for analysis we cannot confirm the defect nor determine a root cause.If a physical sample is forthcoming, the complaint can be re-investigated and a complete analysis will be carried out.This was the first complaint received for this defect and lot.As there is no physical sample available we are unable to confirm the defect and determine the root cause.Further action has not been determined necessary at this time.

Event Description

No additional information.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18236862
• MDR Text Key: 329360114
• Report Number: 9616657-2023-00055
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024
• 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: Lay User/Patient
• Device Catalogue Number: 306546
• Device Lot Number: 3026607
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1