MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL WWD; PISTON SYRINGE

Model Number	301997
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone #: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not necessary at this time.
Event or Problem Description
It was reported that there was poor perforation of package and sterility appeared to be compromised with a bd syringe 10ml ll wwd.This was discovered prior to use.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported that packages are not pre-cut.The hospital has received several batches like this which prevents the integrity of the envelope from being maintained and compromised the sterility of the syringe.

• Brand Name: BD SYRINGE 10ML LL WWD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9720969
• Report Number: 1213809-2020-00102
• Device Sequence Number: 16911328
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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 Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/18/2020
• 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