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

Catalog Number INCORRECT ENTRY

Device Problem Defective Component (2292)

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

Event Date 05/09/2024

Event Type  malfunction  

Event Description

Material # unknown lot # unknown.It was reported by customer that plunger part of 10cc saline flush pops back and doesn't maintain suction or pops out entirely.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (b)(6) 2024.Level of harm: no apparent harm - reached patient/person, close call ahs optional report to cmdsnet (health canada): incident details: plunger part of 10cc saline flush pops back and doesn't maintain suction or pops out entirely.Unexpected or prolonged care? no.Device information device name/description: syringe saline 0.9% flush 10ml sp manufacturer: becton dickinson canada inc manufacturer code/model: 306592 serial or lot number: (b)(6).Expiry date: unknown supplier: (b)(4) supplier catalogue number: bd306592 is device retained: yes number of devices: 1 wipe, contained, labeled? device was clean/not used.Investigation request expected type of investigation: actual device tested, lot review shipping instructions request date (yyyy-mm-dd): 2024-04-23 e-mail address for person holding device: (b)(6).Site shipping address: (b)(6).

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.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported the plunger part of the saline flush pops back and does not maintain suction or pops out entirely.To aid in the investigation, one empty sample with no packaging flow wrap was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the result was within specification.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 306592, lot 3324219.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.

Event Description

No additional information received.Material # 306592 lot # 3324219.It was reported by customer that plunger part of 10cc saline flush pops back and doesn't maintain suction or pops out entirely.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4), date of incident (yyyy-mm-dd): 2024-04-16, level of harm: no apparent harm - reached patient/person, close call ahs optional report to cmdsnet (health canada): incident details: plunger part of 10cc saline flush pops back and doesn't maintain suction or pops out entirely.Unexpected or prolonged care? no.Device information device name/description: syringe saline 0.9% flush 10ml sp, manufacturer: becton dickinson canada inc, manufacturer code/model: 306592, serial or lot number: (b)(6), expiry date: unknown, supplier: (b)(4), supplier catalogue number: (b)(4), is device retained: yes, number of devices: 1, wipe, contained, labeled? device was clean/not used.Investigation request: expected type of investigation: actual device tested, lot review, shipping instructions request date (yyyy-mm-dd): 2024-04-23, e-mail address for person holding device: (b)(4), site shipping address: (b)(4).

• Brand Name: SYRINGE 10ML SALINE FILL CAN SP
• 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: 19203369
• MDR Text Key: 341397095
• Report Number: 1911916-2024-00294
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• 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,Followup
• Report Date: 05/22/2024

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: INCORRECT ENTRY
• Device Lot Number: INCORRECT ENTRY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1