MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE; PISTON SYRINGE

Catalog Number 309657

Device Problem Missing Information (4053)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

It was reported while using bd plastipak¿ 3ml syringe there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have been receiving complaints about these syringes.They are missing numbers and they are uneven.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: two photos were provided to our quality team for investigation.Upon examination of the returned photos, it was observed that two syringes have skewed scale markings and missing half of the graduation lines towards the tip of the syringe.Potential root cause for the scale marking defect is associated with the marking process.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review was completed for provided lot number 2054353.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.

Event Description

It was reported while using bd plastipak¿ 3ml syringe there were scale marking issues.There was no report of patient impact.The following information was provided by the initial reporter: we have been receiving complaints about these syringes.They are missing numbers and they are uneven.

• Brand Name: BD PLASTIPAK¿ 3ML 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 ; 8448235433
• MDR Report Key: 16632029
• MDR Text Key: 312409635
• Report Number: 1213809-2023-00280
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096572
• UDI-Public: (01)00382903096572
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: 2054353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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