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

Catalog Number 309628

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Inflammation (1932)

Event Date 01/10/2018

Event Type  Injury  

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 with the use of the bd luer-lok¿ disposable syringe ¿on (b)(6) 2018, regeneron received a product complaint related to sterility and/or foreign matter concerns.Additional information: the patients from the multiple cases of inflammation were treated by their respective physicians.¿ no further information available.

Manufacturer Narrative

Investigation results: dhr review was performed.All visual inspections were performed as per requirement.Manufacturing dates for batch 7002638 are 1/22/2017 ¿ 1/23/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defects.Batch 7002638 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The batch was manufactured and released according to procedures and specifications.There were no related events for fm and sterilization.There were no changes in the manufacturing methods.There were no changes in sterilization processes for bd catalog number 309628 in the last 3 years.Samples were not provided.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.The appropriate bd business team regularly reviews the collected data for identification of emerging trends.Conclusion: a root cause for the reported issue could not be determined based on the information provided.Based on the sample evaluation: unconfirmed: bd (b)(4) was not able to duplicate or confirm the customer's indicated failure.Capa is not required as no defects were confirmed.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7260066
• MDR Text Key: 99595413
• Report Number: 1213809-2018-00053
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 309628
• Device Lot Number: 7002638
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention