MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 20ML LS S/C 48; PISTON SYRINGE

Catalog Number	302831
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 sterile breach occurred with a syringe 20ml ls s/c 48.The following information was provided by the initial reporter, "it was reported that the packaging on some of the syringes was not sealed.Verbatim: something wasn't sealed in over half of the box.Reporter could not provide any other information he doesn't know if it was the packaging or not and could not provide the customer's first and last name.".
Event or Problem Description
It was reported that sterile breach occurred with a syringe 20ml ls s/c 48.The following information was provided by the initial reporter, "it was reported that the packaging on some of the syringes was not sealed.Verbatim: something wasn't sealed in over half of the box.Reporter could not provide any other information he doesn't know if it was the packaging or not and could not provide the customer's first and last name.".
Additional Manufacturer Narrative
Investigation summary: thirty-nine (39) samples were received from the customer for investigation.Visual examination of the returned samples revealed that thirty-six (36) of the returned samples were properly sealed and that three (3) of the returned samples were not properly sealed in that the top web of the packages did not completely cover the blister pack.A machine malfunction in the packaging machine could result in the top web getting off center resulting in the top web not covering the product when sealing.The blister packs were then packaged automatically without being caught by the operators.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: SYRINGE 20ML LS S/C 48
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8671686
• Report Number: 1911916-2019-00566
• Device Sequence Number: 2005600
• Product Code: FMF
• UDI-Device Identifier: 30382903028314
• UDI-Public: 30382903028314
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 07/31/2023
• Device Catalogue Number: 302831
• Device Lot Number: 8178747
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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