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

Catalog Number 30654778

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (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 #:30654778 batch#:3261048.It was reported by customer that the flush cracked down the barrel of the syringe when nurse flushed the line, caused saline to leak out the side of the syringe.

Manufacturer Narrative

(b)(4), follow up for device evaluation.It was reported the flush cracked down the barrel of the syringe.To aid in the investigation, one empty sample with no packaging flow wrap or tip cap was received for evaluation by our quality team.A visual inspection was performed.The plunger rod-rubber stopper is all the way down, and the syringe barrel has a crack 2 1/4" long.No other defects or imperfections were observed.This defect could occur if there was a jam during the manufacturing process.A device history record review was completed for provided material number 30654778, lot 3261048.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.The sample will be shown to associates for awareness.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 is confirmed.

Event Description

Additional information received, item was being used on a patient but no harm came from it.Rn noted leaking and stopped flushing the iv.Only 1 occurrence that i am aware of.Material #:30654778, batch#:3261048.It was reported by customer that the flush cracked down the barrel of the syringe when nurse flushed the line, caused saline to leak out the side of the syringe.Verbatim: 2782-pc - 10ml flush cracked down the barrel of the syringe when nurse flushed the line, caused saline to leak out the side of the syringe.Additional information: to whom it may concern, return label send to: (b)(6).Item was being used on a patient but no harm came from it.Rn noted leaking and stopped flushing the iv.Only 1 occurrence that i am aware of.

• 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: 18837754
• MDR Text Key: 337784609
• Report Number: 1911916-2024-00160
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30654778
• Device Lot Number: 3261048
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1