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

Model Number 400174

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd® plastic nrfit¿ syringe was with or without luerlock.The following information was provided by the initial reporter, translated from dutch to english: we have found that for item number 400174 with lot number 1041220, there are products with and without luerlock.

Manufacturer Narrative

Investigation summary: eighty-three samples and five photos were provided to our quality team for investigation.Through visual inspection, it was observed that nineteen sample had 10ml luer lock standard barrel instead of 10ml nrfit lock barrel.Potential root cause for the mixed product defect is associated with inadequate line clearance on the marking machinery.A corrective action project was opened to further investigate these defect.Manufacturing personnel will be notified of this incident and additional training will be provided.A device history record review was completed for provided lot number 1041220.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation with the samples analysis the symptom reported is confirmed.

Event Description

It was reported that the bd® plastic nrfit¿ syringe was with or without luerlock.The following information was provided by the initial reporter, translated from dutch to english: we have found that for item number 400174 with lot number 1041220 there are products with and without luerlock.

• Brand Name: BD® PLASTIC NRFIT¿ SYRINGE
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15395696
• MDR Text Key: 305620884
• Report Number: 1213809-2022-00552
• Device Sequence Number: 1
• Product Code: QEH
• UDI-Device Identifier: 00382904001742
• UDI-Public: 00382904001742
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K192538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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
• Device Operator: Other
• Device Model Number: 400174
• Device Catalogue Number: 400174
• Device Lot Number: 1041220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1