MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML ST BULK CONVENIENCE PAK; 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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
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 there was foreign matter as well as scale marking issues with a bd syringe 1ml st bulk convenience pak, this was discovered before use.The following information was provided by the initial reporter: material no.309701, batch no.8274580.(2 of 2).It was reported that there was issues with the 1 ml bd syringes slip tip tray.Six were found with different types of contaminants, and one was found with a scale marking issue.Additional information provided by reporter: a brownish foreign matter (dirt) noticed on the plunger of 1ml syringe.This was detected upon opening the tray prior to using for filling.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants.One empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.-please note that all of the issues were detected prior to filling products into them so no patient safety was affected.
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.
Event or Problem Description
It was reported that there was foreign matter as well as scale marking issues with a bd syringe 1ml st bulk convenience pak, this was discovered before use.The following information was provided by the initial reporter: material no.309701, batch no.8274580 (2 of 2).It was reported that there was issues with the 1 ml bd syringes slip tip tray.Six were found with different types of contaminants, and one was found with a scale marking issue.Additional information provided by reporter: a brownish foreign matter (dirt) noticed on the plunger of 1ml syringe.This was detected upon opening the tray prior to using for filling.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants.One empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.Please note that all of the issues were detected prior to filling products into them so no patient safety was affected.

• Brand Name: BD SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8732277
• Report Number: 1213809-2019-00655
• Device Sequence Number: 2572313
• 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: foreign,other,user facility
• 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