MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN; PISTON SYRINGE

Model Number 309581

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/09/2022

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 luer-lok¿ syringe with attached needle 25 g x 1 in experienced a open package.The following information was provided by the initial reporter: i work as an rn at a family doctors office in guelph ontario.We received an order of syringes and upon my opening the box today and almost stabbed myself with an unpackaged 25g 1¿ syringe, lying right at the top of the box.

Event Description

It was reported that the bd luer-lok¿ syringe with attached needle 25 g x 1 in experienced a open package.The following information was provided by the initial reporter: i work as an rn at a family doctors office in guelph ontario.We received an order of syringes and upon my opening the box today and almost stabbed myself with an unpackaged 25g 1¿ syringe, lying right at the top of the box.

Manufacturer Narrative

Investigation summary: four photos were provided to our quality team for investigation.Through visual inspection, a loose, unpackaged and unshielded syringe with needle observed on the top of sealed samples inside the box.Potential root causes for the unpackaged syringe defect are associated with the packaging process.A quality alert will be sent to out the manufacturing facility for this defect.Furthermore, a device history record review was completed for provided lot number 0281238.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN
• 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: 15341873
• MDR Text Key: 305541204
• Report Number: 1213809-2022-00537
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: 30382903095811
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309581
• Device Catalogue Number: 309581
• Device Lot Number: 0281238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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