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

Catalog Number	306553
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 red foreign matter was found inside 2 bd posiflush¿ sf saline syringes during a work order creation.The following information was provided by the initial reporter: "discovery of red substance / debris/ contamination within 2 each 306553 saline syringe 10ml lot 2110682.Our assembly team found red debris / contamination within the syringe pack and seal of 2 each during work order creation.Qa approved the remainder of lot 2110682 via ansi sampling, no further debris was found, there is no material on hold.".
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 306553 and lot number 2110682.The review did not reveal any non-conformances during the production process that could have contributed to the reported defect.To aid in the investigation of this issue, one (1) physical sample was returned for evaluation by our quality engineer team.Fourier-transform infrared (ftir) spectroscopy was performed on the foreign material.Based on the ftir results and an inspection of the foreign material, it was determined that the material was most likely a piece of a suction cup or brake hose in the multivac machine.In order to confirm this determination, the piece of foreign material along with samples of a suction cup and brake hose were sent for comparison testing.The comparison test results confirmed that the foreign material was most likely a piece of the brake hose from the multivac.The most probable cause for this incident is related to the wearing of the hydraulic tubing within the brake housing of the multivac.In order to prevent this defect from recurring, the brake system will be changed and captured under a local change control.H3 other text : see h10.
Event or Problem Description
It was reported that red foreign matter was found inside 2 bd posiflush¿ sf saline syringes during a work order creation.The following information was provided by the initial reporter: "discovery of red substance / debris/ contamination within 2 each 306553 saline syringe 10ml lot 2110682.Our assembly team found red debris / contamination within the syringe pack and seal of 2 each during work order creation.Qa approved the remainder of lot 2110682 via ansi sampling, no further debris was found, there is no material on hold.".

• Brand Name: BD POSIFLUSH¿ SF SALINE 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: 15825360
• Report Number: 9616657-2022-00039
• Device Sequence Number: 14988276
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/28/2022

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: 03/31/2025
• Device Catalogue Number: 306553
• Device Lot Number: 2110682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 01/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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