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 10/03/2023

Event Type  malfunction  

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

Pr (b)(6) : 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

(b)(4) additional information received.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.Verbatim: rcc received complaint via phone.306547l: lot # 2349201, syr 10ml pump compatible saline 10ml fil.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.Icare # - (b)(4).(b)(6).Phone (b)(6).Date of event? 2.Physical sample available/not available.3.Was there any patient involvement? 4.If yes, what is the patient outcome? are there any adverse events/serious injuries? 5.Was there a delay of, or change in, the course of treatment due to the event? 6.What type of procedure is being performed? 7.Any adverse event or serious injury reported to patient or healthcare professional? 1.10-03-2023.2.Available.3.Yes.4.No harm.5.No.6.Ecmo.7.No.

Manufacturer Narrative

(b)(4) follow up for device evaluation.It was reported the tip broke off in a step cock.To aid in the investigation, three empty samples with no packaging flow wraps or tip caps were received for evaluation by our quality team.Together with the samples, three step cocks were received.A visual inspection was performed.Two of the samples have no defects or imperfections.One sample has the syringe barrel luer tip broken off.Two of the step cocks have a syringe barrel luer tip in them.The syringe barrel luer tip broken appears to be twisted when broken off.It could be possible the step cock induced the symptom.No other defects or imperfections were observed.A device history record review was completed for provided material number 306547, lot 2349201.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.Based on the investigation and with the returned 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18046658
• MDR Text Key: 327049624
• Report Number: 1911916-2023-00811
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023
• 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: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1