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

Catalog Number	301997
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that brown foreign matter was found embedded in a 10ml bd syringe luer-lok tip prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted field: device returned to manufacture: yes.
Event or Problem Description
It was reported that brown foreign matter was found embedded in a 10ml bd syringe luer-lok tip prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one loose 10ml assembled syringe was received and reported to be from batch #unknown (p/n 301997).The sample was visually evaluated.The syringe barrel was found to have red foreign matter embedded in the barrel wall.One piece is located to the left of the 1ml gradline and is larger than level 3 in size the second is located opposite the 3ml gradline and is level three in size.Both observed pieces of foreign matter are embedded in the barrel wall and are rejectable per product specification.Potential root cause for the foreign matter defect is associated with the molding process.However, a complete investigation could not be performed because the batch # is unknown.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.
Event or Problem Description
It was reported that brown foreign matter was found embedded in a 10ml bd syringe luer-lok tip prior to use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD SYRINGE LUER-LOK TIP
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7554535
• Report Number: 1213809-2018-00308
• Device Sequence Number: 2512378
• Product Code: FMF
• UDI-Device Identifier: 00382903019977
• UDI-Public: 00382903019977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 301997
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018; 05/09/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/18/2018; 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other