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

Catalog Number 306592

Device Problem Material Separation (1562)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

Material#: 306546 batch#:3173798 it was reported by the customer that they had no blood return from patients lateral lumen of double port-a-cath.Writer attempted to turbulent flush with prefilled saline syringe (x2) and each time the plunger became unscrewed/detached from black rubber stopper.Plunger came all the way out of syringe each time.Lot#3173798 for each syringe.Verbatim: rcc received a complaint via email.Email(s) attached.Chc complaint reference #: pcs240313gpxtzi hospital complaint reference #: sims event #: (b)(4).Customer (hospital) name: (b)(6).Customer address: (b)(6).Correspondence language: english cat# of product being complained: bd306592 description of product: syringe 10ml saline fill 30ea/bx 16bx/ca lot or s/n: (b)(6).Complaint category: fail to function / defective reportable: no incident date: (b)(6) 2024 hospital complaint reference #: sims event #: (b)(6).Details of complaint (reported issue): no blood return from patients lateral lumen of double port-a-cath.Writer attempted to turbulent flush with prefilled saline syringe (x2) and each time the plunger became unscrewed/detached from black rubber stopper.Plunger came all the way out of syringe each time.Lot#3173798 for each syringe.Complaint noticed: during / after use problem frequency: a few times customer exposure: patient injury: no has health canada been informed? unknown qty affected: 2 ea samples available? no is customer requesting an rga?: no return qty:.

Manufacturer Narrative

Pr 9878634: 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#: 306546 batch#:3173798 it was reported by the customer that they had no blood return from patients lateral lumen of double port-a-cath.Writer attempted to turbulent flush with prefilled saline syringe (x2) and each time the plunger became unscrewed/detached from black rubber stopper.Plunger came all the way out of syringe each time.Lot#3173798 for each syringe.Verbatim: rcc received a complaint via email.Email(s) attached.Chc complaint reference #: (b)(4) hospital complaint reference #: sims event #:(b)(4).Customer (hospital) name: xxxxxxxxxxxx customer address:xxxxxxxxxxx, xxxxxxxxxxxx contact name: xxxxxxx phone: xxxxxxx e-mail: xxxxxxxx correspondence language: english cat# of product being complained: bd306592 description of product: syringe 10ml saline fill 30ea/bx 16bx/ca lot or s/n:(b)(6) complaint category: fail to function / defective reportable: no incident date: 15 jan 2024 hospital complaint reference #: sims event #:(b)(4).Details of complaint (reported issue): no blood return from patients lateral lumen of double port-a-cath.Writer attempted to turbulent flush with prefilled saline syringe (x2) and each time the plunger became unscrewed/detached from black rubber stopper.Plunger came all the way out of syringe each time.Lot#3173798 for each syringe.Complaint noticed: during / after use problem frequency: a few times customer exposure: patient injury: no has health canada been informed? unknown qty affected: 2 ea samples available? no is customer requesting an rga?: no return qty:.

Manufacturer Narrative

(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3173798.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.All bd posiflush¿ pre-filled syringes are designed to ensure maximum patient safety.The stopper and plunger rod have special design features which stop pull-back on the plunger rod, which may have allowed the stopper to travel behind its original parked location and enter a non-sterile region.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.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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• 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: 18928929
• MDR Text Key: 338753544
• Report Number: 1911916-2024-00194
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024
• 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: Health Professional
• Device Catalogue Number: 306592
• Device Lot Number: 3173798
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1