MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH; SALINE VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd posiflush tip broke.The following information was provided by the initial reporter: after nurse had accessed patient port sterilely, nurse went to flush line with saline syringe via stopcock.After flushing nurse went to twist off flush and tip of flush broke off still connected to stopcock.Nurse able to sterilely replace stopcock and continue procedure.¿ no adverse event.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 306553 and lot number 3327120.The review did not reveal any possible non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, the affected sample, along with the accessories used, was returned for evaluation by our quality team.Through analysis of the sample, the syringe tip was observed broken.Based on the investigation results, the nature of the damage to the luer tip on the syringe does not appear to be molding or manufacturing related.The damage to the luer and the fact that it appears to be completely fused with the accessory device suggests that it most likely resulted from the interaction between the materials.However, an exact cause could not be determined.This is the first report received for this type of issue on material number 306553 and lot number 3327120.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD POSIFLUSH
• Common Device Name: 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: 20185642
• Report Number: 9616657-2024-00025
• Device Sequence Number: 21065689
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 306553
• Device Lot Number: 3327120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown