MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Model Number 309628

Device Problem Missing Information (4053)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported that an unspecified number of bd luer-lok¿ tip syringes experienced missing scale markings.The following information was provided by the initial reporter: the graduation marks after 0.9ml are not visible.Users note a lack of graduations below 0.9 ml on the 1 ml syringe.This incident is repetitive.Consequences: production delay.Change of device.Risk of dosing error of drug substances.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19-dec-2022.H6: investigation summary it was reported there was a lack of graduations.To aid in the investigation, one sample and one photo of a 1ml luer-lok syringe was received for evaluation by our quality team.The sample received is loose and missing all the print below the 0.9ml graduation line on the barrel.The image shows the loose syringe with the condition described.The condition observed is non-conforming per product specification and is associated with the marker process.A device history record review was complete for provided material number 309628, lot number 2049555.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2049555 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

Event Description

It was reported that an unspecified number of bd luer-lok¿ tip syringes experienced missing scale markings.The following information was provided by the initial reporter: the graduation marks after 0.9ml are not visible.Users note a lack of graduations below 0.9 ml on the 1 ml syringe.This incident is repetitive.Consequences: production delay.Change of device.Risk of dosing error of drug substances.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15872151
• MDR Text Key: 307802474
• Report Number: 1911916-2022-00678
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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 Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 2049555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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