MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number 301027

Device Problem Illegible Information (4050)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

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 scale markings on 278 bd plastic non-sterile luer-lok¿ tip syringes were light.The following information was provided by the initial reporter: "today we have received the delivery of order (b)(4).We cannot accept whole batch of 5ml syringes.".

Manufacturer Narrative

H.6.Investigation summary: one photo was received by bd for evaluation.A quality engineer was able to review the photo of a syringe 5ml ll bns from lot #2224563 regarding item #301027 with the reported complaint of ¿scale marking light¿.The photo was examined, and the reported issue was determined to be related to a print issue.Per (b)(4).These print defects fall under major print defects for gross ink smears, severe ink blurring/double print and missing/scratch print.This is a critical issue since it will affect the dosing.A quality improvement project has been opened to address and improve the quality of prints on all lines.A review of the device history record was completed for batch #2224563.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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.Based on the above, no additional investigation and no corrective and preventative actions (capa)/situation analysis (sa) is required at this time.H3 other text : see h10.

Event Description

It was reported that the scale markings on 278 bd plastic non-sterile luer-lok¿ tip syringes were light.The following information was provided by the initial reporter: "today we have received the delivery of order (b)(4).We cannot accept whole batch of 5ml syringes.".

• Brand Name: BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16143049
• MDR Text Key: 308589668
• Report Number: 1920898-2023-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K980987
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301027
• Device Lot Number: 2224563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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