MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number	306553
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to using a bd posiflush¿ sterile field (sf) saline syringe, in 10ml syringe, the syringe barrel was dented.The following information was provided by the initial reporter: sterile syringe in vad access kit was dented.
Event or Problem Description
It was reported that prior to using a bd posiflush¿ sterile field (sf) saline syringe, in 10ml syringe, the syringe barrel was dented.The following information was provided by the initial reporter: sterile syringe in vad access kit was dented.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided material number 306553 and lot number 1118536.The review revealed two potentially related non-conformances during the production process that could have contributed to the reported incident.However, all product associated with the detected non-conformances was held for inspection and any affected material was scrapped per procedures.At this time, neither a physical sample nor a picture sample has been received to further investigate the reported issue and determine a manufacturing related cause.

• Brand Name: BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10ML SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14336481
• Report Number: 9616657-2022-00015
• Device Sequence Number: 5312833
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 1118536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown