MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 309653

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/02/2023

Event Type  malfunction  

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use there were scale marking permanency issues.There was no report of patient impact.The following information was provided by the initial reporter: the syringes markings came off on the caregiver¿s gloves.

Manufacturer Narrative

H6: investigation summary: it was reported the scale markings came off the syringe.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed and the syringe has an incomplete scale marking.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if there is a jam during the syringe barrel printing process.A device history record review was completed for provided material number 309653, lot 2327929.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE
• 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 ; 8448235433
• MDR Report Key: 16799139
• MDR Text Key: 313917748
• Report Number: 1911916-2023-00251
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096534
• UDI-Public: (01)00382903096534
• 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
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309653
• Device Lot Number: 2327929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2022
• 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