MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE NRFIT¿ LOK; PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT

Catalog Number	400173
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe nrfit¿ lok stopper was defective / damaged.The following information was provided by the initial reporter: product number: bd® 5 ml syringe nrfit¿ lok.Reference number/sku: (b)(4).Lot/serial number: (b)(6).Expiration date: 31-12-2024.Problem encountered: anomaly observed in the stopper while pulling liquid inside.Additional information provided: could you please provide event occurrence date? 7th august 2024.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no, the event occurred as part of our internal testing for assessing the performance of the device.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - stopper defective / damaged.One photo of a 5ml nrfit syringe was provided to our quality team for investigation.The photo shows a close-up image of one loose syringe with the stopper jammed between the barrel and the plunger rod.The condition observed is non-conforming per product specification.Potential root cause for the stopper jammed defect is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 0013110.A notification for this defect was written during the production of this batch.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.These conditions are occurring below their expected frequency, so no corrective action is required at this time.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE NRFIT¿ LOK
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT
• 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: 20563245
• Report Number: 1213809-2024-00770
• Device Sequence Number: 7816712
• Product Code: QEH
• UDI-Device Identifier: 00382904001735
• UDI-Public: (01)00382904001735(11)200113(17)241231(10)0013110
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/27/2024

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: 12/31/2024
• Device Catalogue Number: 400173
• Device Lot Number: 0013110
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown