MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 309646

Device Problem Inaccurate Information (4051)

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

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd luer-lok¿ syringe had the wrong product in the box.There was no report of patient impact.The following information was provided by the initial reporter: details of complaint (reported issue): the box is labelled bd309646 but inside is bd309657.

Event Description

It was reported that bd luer-lok¿ syringe had the wrong product in the box.There was no report of patient impact.The following information was provided by the initial reporter: details of complaint (reported issue): the box is labelled bd309646 but inside is bd309657.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 17-feb-2023.H6: investigation summary one hundred ninety-seven sealed packaged in an opened carton box were provided to our quality team for investigation.Through visual inspection, it was observed that cartons outside label mismatched the product inside the box.The carton box label stated 5ml ll, material number 309646, batch number 2221570, and a quantity of 125.However, the products inside the box were 197 sealed packaged 3ml ll with material number 309657 and batch number 2215946 printed on their top web packages.Potential root cause for the incorrectly labeled box defect is associated with a failure to follow the packaging material handling processes.This defect most likely occurs due to an inadequate line clearance after production of the 3ml batch likely led to the box being left unattended in a location where a palletizing operator may have mistakenly placed it on the 5ml line utilizing the same box.As a corrective action, re-education of all palletizing operators and team members associated with the packaging of the 3ml and 5ml lots to applicable procedures for line clearance and disposing of product properly to prevent mixes will be performed.A device history record review was completed for provided lot number 2221570.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK¿ 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: 16399556
• MDR Text Key: 309982897
• Report Number: 1213809-2023-00099
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096466
• UDI-Public: (01)00382903096466
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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
• Device Operator: Other
• Device Catalogue Number: 309646
• Device Lot Number: 2221570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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