MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE NRFIT¿ SLIP; PISTON SYRINGE

Catalog Number	400051
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe nrfit¿ slip stopper was defective/damaged.The following information was provided by the initial reporter: "when the nrfit syringe slip 5ml was opened, the plunger tip seems damaged.The nrfit syringe slip 5ml was not used to treat the patient.".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation.One video and one photo of a 5ml nrfit syringe were received by bd.A quality engineer was able to review the photos from lot number 0083149 regarding material number 400051.Both the photo and video show the stopper jammed between the barrel and the plunger rod.The condition observed is non-conforming per product specification.A notification for this defect was written during the production of this lot.A requalification was performed, and the line cleared of defects.However, it is possible a limited number of pieces with this condition were able to escape detection.Potential root cause for the jammed stopper defect is associated with the assembly process.A device history record review was completed for provided lot number 0083149 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE NRFIT¿ SLIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18167094
• Report Number: 1213809-2023-01291
• Device Sequence Number: 15088553
• Product Code: QEH
• UDI-Device Identifier: 00382904000516
• UDI-Public: (01)00382904000516
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: Other
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 400051
• Device Lot Number: 0083149
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown