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

Catalog Number 306547

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a040103 - material fragmentation.Patient problem code: f26 ¿ no health consequences or impact.

Event Description

Material#: 306547, batch#: 2349201.It was reported by customer that tip had broken off into a stop caulk.Happened 2 times in 1 week.He said it may be into the stop caulk because this is the only department that uses it and has had the tips break, but they would still like to report the issue.Occurred at the interface of the ecmo unit.The syringe was not saved.We had to change out the stopcock on the ecmo pigtail.Unknown how it broke or when.

Manufacturer Narrative

(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306547 and lot number 2349201.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.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.

Event Description

Additional information received.Material #: 306547 batch #: 2349201.It was reported by customer that the end of the ns flush broke off in the three way stopcock on an ecmo circuit.This is the second time in 7 days, refer to icare #(b)(4).No harm to the patient or staff, as proper precautions were taken while accessing the ecmo circuit and staff were informed of the first event.The stopcock on the circuit was replaced.Verbatim: rcc received a complaint via email.Email(s) attached.End of the ns flush broke off in the three way stopcock on an ecmo circuit.This is the second time in 7 days, refer to icare #(b)(4).No harm to the patient or staff, as proper precautions were taken while accessing the ecmo circuit and staff were informed of the first event.The stopcock on the circuit was replaced.Both the ns flush which broke and the stopcock have been retained in the ecmo manager's office.Was there any harm or injury to the patient, health care provider, or any other person? no was there a delay of or change in the course of treatment due to the event? please provide any available details.Yes, with need to acquire new supplies.If not answered in question #2, what was the medication administered to the patient? no.Is the event date known? 10/10/2023.Is this sample available for investigation? yes.If not, is a photo sample available? no.Please add ¿icare (b)(4)¿ as the other external reference # for this complaint.Please note that the product information was reported as: bd normal saline posiflush lot #2349201 (that¿s on the syringe from the second event).Please note that samples are available for this complaint (icare (b)(4)) and icare (b)(4), it looks like that last icare has not been formally reported to us, consider opening a second complaint for this icare.Please work on a shipping label for these samples.If the label is ready before i come back from pto, please feel free to send it directly to the customer.

• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18047556
• MDR Text Key: 327068036
• Report Number: 1911916-2023-00812
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: 2349201
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1