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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
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 2 bd luer-lok¿ syringes in the bulk sterile pharmacy convenience tray were found with foreign contaminates in the packaging 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: one photo of a total of 14 syringes and one needle assembly was received and evaluated.One was a loose 3ml syringe that was previously investigated.Thirteen were loose 1ml syringes and it was unclear which syringe this complaint was issued for.Therefore, this defect cannot be confirmed.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.The reported defect was not identified in the photo received.Since no samples displaying the reported condition were received corrective actions are not necessary.
Event or Problem Description
It was reported that 2 bd luer-lok¿ syringes in the bulk sterile pharmacy convenience tray were found with foreign contaminates in the packaging 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.

• 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: 8730915
• Report Number: 1213809-2019-00650
• Device Sequence Number: 19476159
• 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