MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD HYPO- POSIFLUSH SYRINGE 10ML; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Leak/Splash (1354)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that bd hypo- posiflush syringe 10ml leaked within the unit package.The following information was provided by the initial reporter: the complaint i got was ¿ there have been a handful of the 10 ml saline flushes that are leaking into their packaging¿.I¿m not sure if the every leaking flush is from the same container or lots, nursing sent them to pharmacy instead of back to us.The one i have in front of me is lot # 3250016!.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

A device history record review was completed for provided material number 306546 and lot number 3250016.The review did not reveal any possible non-conformances during the production process that could have contributed to the reported incident.To aid in the investigation of this issue, the affected physical sample was returned for evaluation by our quality team.The syringe sample was still within the original unopened packaging.Through analysis of the sample, the stopper component was found out of proper position.Through the investigation results, the most probable cause for the leaking syringe was the stopper being out of position and/or a loose tip cap.However, there were no non-conformances identified during the production process.As this is the first report received for this type of defect on material number 306546 and lot number 3250016, further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: BD HYPO- POSIFLUSH SYRINGE 10ML
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18918074
• MDR Text Key: 337857710
• Report Number: 9616657-2024-00010
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024
• 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: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3250016
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1