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

Catalog Number 306547

Device Problem Material Separation (1562)

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

Event Date 04/17/2024

Event Type  malfunction  

Event Description

Material # 306547.Lot # 4003449.It was reported by customer that when using the bd posiflush 10ml saline flush, they are able to easily flush saline into the iv but when they pull back to check for blood return (frequent practice in chemo suite), the plunger rod disconnect from the stopper and pops out.Verbatim: several nurses have reported that when using the bd posiflush 10ml saline flush, they are able to easily flush saline into the iv but when they pull back to check for blood return (frequent practice in chemo suite), the plunger rod disconnect from the stopper and pops out.They are able to screw it back in but they feel it wasn't secure to begin with.This poses a safety hazard as they are connected to the patient's iv access and (potentially) blood.

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.H3 other text : see h10 manufacture narrative.

Event Description

No additional information received.Material # 306547.Lot # 4003449.It was reported by customer that when using the bd posiflush 10ml saline flush, they are able to easily flush saline into the iv but when they pull back to check for blood return (frequent practice in chemo suite), the plunger rod disconnect from the stopper and pops out.Verbatim: several nurses have reported that when using the bd posiflush 10ml saline flush, they are able to easily flush saline into the iv but when they pull back to check for blood return (frequent practice in chemo suite), the plunger rod disconnect from the stopper and pops out.They are able to screw it back in but they feel it wasn't secure to begin with.This poses a safety hazard as they are connected to the patient's iv access and (potentially) blood.

Manufacturer Narrative

(b)(4) follow up.It was reported the plunger rod disconnects from the stopper and pops out.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows an empty prefilled syringe with the plunger rod removed.No other information could be obtained from the photo.It could be possible the customer is not using the product as intended.This product is designed to push down the syringe plunger rod-rubber stopper while expelling the saline solution.After, the product should be discarded.The flush is not designed to pull the plunger rod-rubber stopper back.The stopper and plunger rod have special design feature which stops pull-back on the plunger rod.Pulling back on the plunger rod, either before, during or after the administration of saline flush may lead to plunger rod being separated from the stopper, especially when the plunger rod is twisted during pull-back motion.This safety mechanism prevents the solution from entering a non-sterile area of the syringe, helping to reduce the risk of solution contamination and thereby ensuring patient safety.A device history record review was completed for provided material number 306547, lot 4003449.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 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: 19169985
• MDR Text Key: 341698775
• Report Number: 1911916-2024-00279
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

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: 4003449
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1