MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 301073

Device Problems Corroded (1131); Malposition of Device (2616); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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¿ syringes were found with damage, particulate matter contamination, inclusions, misaligned gaskets, and scale marking issues.

Event Description

It was reported that multiple bd luer-lok¿ syringes were found with 121 occurrences of damage, 40 occurrences of particulate matter contamination, 7 occurrences of inclusions, 43 occurrences of misaligned gaskets, and 43 occurrences of scale marking issues.

Manufacturer Narrative

Describe event or problem: it was reported that multiple bd luer-lok¿ syringes were found with 121 occurrences of damage, 40 occurrences of particulate matter contamination, 7 occurrences of inclusions, 43 occurrences of misaligned gaskets, and 43 occurrences of scale marking issues.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Root cause description: no root cause can be determined as no samples were received.Rationale: 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.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8206584
• MDR Text Key: 131762604
• Report Number: 1213809-2018-01001
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 301073
• Device Lot Number: 8001759
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other