MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVENOUS CATHETER

Catalog Number	306553
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd posiflush¿ sf saline syringe had dirty packaging included through the sterile barrier.The following information was provided by the initial reporter : we have sf bd 10ml syringes that has something non-sterile packaged with it (some sort of dirty packaging).
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 5 bd posiflush¿ sf saline syringe had dirty packaging included through the sterile barrier.The following information was provided by the initial reporter : we have sf bd 10ml syringes that has something non-sterile packaged with it (some sort of dirty packaging).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28sep2022.A device history record review was completed for provided material number 306553 and lot number 2117908.There were no possible non-conformances detected during the production of this lot number that could have contributed to the reported issue.To aid in the investigation of this issue, one picture sample and the affected physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, foreign matter was observed within the product packaging.Based on the investigation results, the most probable cause for the observed foreign matter is related to a broken waste bin sensor at the multivac machine.The sensor has been replaced and tested to ensure any issues have been resolved.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Common Device Name: INTRAVENOUS CATHETER
• 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: 15473979
• Report Number: 9616657-2022-00032
• Device Sequence Number: 2892147
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: (01)00382903065530
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 04/30/2025
• Device Catalogue Number: 306553
• Device Lot Number: 2117908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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