MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306553
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 the bd posiflush¿ sf saline syringe packaging tore while opening and left paper shards in the sterile field.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "customer reported the chads from the perforation are flaking onto the sterile field.When they're opened from paper pack, some of the paper seems to be flaking off onto the sterile field.They are not sure the exact amount so far that have had the issue.Is there any adverse event occurred? no is there any patient harm, injury, or negative outcome that has not already been discussed? no".
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided material number 306553 and lot number 2243740.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, four (4) samples were returned for evaluation by our quality team.Two (2) of the blister packages were separated and opened with the syringes still inside.The remaining two (2) syringes were separated, and the blister packages were opened.Through the inspection, we can confirm that the most probable cause for this issue was fiber tearing.A small amount of fiber tearing naturally occurs when separating individual blisters and when separating the paper top web from the plastic bottom web.
Event or Problem Description
It was reported that the bd posiflush¿ sf saline syringe packaging tore while opening and left paper shards in the sterile field.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "customer reported the chads from the perforation are flaking onto the sterile field.When they're opened from paper pack, some of the paper seems to be flaking off onto the sterile field.They are not sure the exact amount so far that have had the issue.-is there any adverse event occurred? no.-is there any patient harm, injury, or negative outcome that has not already been discussed? no".

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17442493
• Report Number: 9616657-2023-00029
• Device Sequence Number: 14179447
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: 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): 08/23/2023

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: 08/31/2025
• Device Catalogue Number: 306553
• Device Lot Number: 2243740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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