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

Catalog 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
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 10ml ll wwd packaging did not have the precut perforations.This was found prior to use.The following information was provided by the initial reporter: verbatim: 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.
Additional Manufacturer Narrative
H.6 investigation summary: 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.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.
Event or Problem Description
It was reported that the syringe 10ml ll wwd packaging did not have the precut perforations.This was found prior to use.The following information was provided by the initial reporter: verbatim: 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: SYRINGE 10ML LL WWD
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9727975
• Report Number: 1213809-2020-00103
• Device Sequence Number: 16328802
• Product Code: FMF
• UDI-Device Identifier: 00382903019977
• UDI-Public: 00382903019977
• 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,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 301997
• Device Lot Number: 8323956
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 02/19/2020
• 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