MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd luer-lok¿ syringe in the bulk sterile pharmacy convenience tray was found with foreign contaminates in the packaging and barrel, and a scale marking defect on the barrel before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: foreign unidentified matters were observed inside two filled syringes during particulate matter inspection.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants.Four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel.One empty 3ml bd syringe -luer lock in tray was found with some type of contaminant.One empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.One blunt fill needle with filter was found with some kind of defect.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe in the bulk sterile pharmacy convenience tray was found with foreign contaminates in the packaging and barrel, and a scale marking defect on the barrel before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: foreign unidentified matters were observed inside two filled syringes during particulate matter inspection.-six empty 1ml bd syringe -slip tip tray were found with different types of contaminants -four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel -one empty 3ml bd syringe -luer lock in tray was found with some type of contaminant -one empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect -one blunt fill needle with filter was found with some kind of defect.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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.H3 other text : see h.10.

• Brand Name: BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8730919
• Report Number: 1213809-2019-00651
• Device Sequence Number: 11422694
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 309701
• Device Lot Number: 8274580
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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