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

Catalog Number 306547

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/09/2024

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.H3 other text : see h10 manufacture narrative.

Event Description

Material #: 306547 batch #: 3297968 it was reported by customer that one of their clinicians found a piece of plastic inside a flush syringe.Verbatim: one of our clinicians found a piece of plastic inside a flush syringe ref# (b)(4) lot# 3297968.We have the product sequestered as well as the attached pictures.Can you please let us know if you would like to send the site (hossam afifi, supply chain site supervisor) shipping information to send the affected product to your quality department? also, amanda (cc¿d) is the nursing supervisor in our pediatric unit at fairview ridges where this was discovered if you had further clinical questions.

Event Description

Additional information received.The plastic piece was noticed before the syringe was used on a patient, so there was no patient involvement.Material #: 306547.Batch #: 3297968.It was reported by customer that one of their clinicians found a piece of plastic inside a flush syringe.Verbatim: one of our clinicians found a piece of plastic inside a flush syringe ref# (b)(4) lot# 3297968.We have the product sequestered as well as the attached pictures.Can you please let us know if you would like to send the site (hossam afifi, supply chain site supervisor) shipping information to send the affected product to your quality department? also, amanda (cc¿d) is the nursing supervisor in our pediatric unit at fairview ridges where this was discovered if you had further clinical questions.

Manufacturer Narrative

Pr 9691258 follow up for device evaluation.It was reported there was a piece of plastic inside a flush syringe.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, four photos were provided for evaluation by our quality team.Three photos show a prefilled syringe with a piece of plastic in it.The fourth photo shows a piece of plastic, that appears to be from a syringe barrel flange, being held in a human hand.No other defects or imperfections were observed.This defect could occur if there was jam before the filling process inducing a piece of plastic falling into another syringe.A device history record review was completed for provided material number 306547, lot 3297968.The review did not reveal any detected quality issues during the production of this lot that could have contributed for the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the processes were performed.The rails were aligned, the flow of product was good, and no jams were observed.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.

• 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: 18757350
• MDR Text Key: 336979101
• Report Number: 1911916-2024-00131
• Device Sequence Number: 1
• Product Code: NGT
• 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: Company Representative
• 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

• 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: 3297968
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1