MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 300144

Device Problem Volume Accuracy Problem (1675)

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

Event Date 07/26/2021

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 had faded scale markings.The following information was provided by the initial reporter: "faded scale marking.".

Manufacturer Narrative

H.6.Investigation: one photo was received by our quality team for evaluation.From the photos, the scale marking was observed to be faded and foreign matter was observed on the barrel surface.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.From the photos, faded scale marking and foreign matter was observed on the barrel surface.The faded scale marking might have occurred during sample handling.Therefore, the root cause could not be determined.

Event Description

It was reported that the bd luer-lok¿ syringe had faded scale markings.The following information was provided by the initial reporter: "faded scale marking".

• Brand Name: BD LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12355958
• MDR Text Key: 267821557
• Report Number: 8041187-2021-00765
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300144
• Device Lot Number: 0010174
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1