MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1 RB; PISTON SYRINGE

Model Number	309644
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 an unspecified number of syringe 10ml ll w/ndl 20x1 rb experienced product damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 309644 batch no.: 4139688.Clarification: upon speaking with the customer, he reported the box was ripped, syringes were missing and there was a big blue sticker on the box.He could not determine if the box came from a distributor or bd that way.He states he still has the box and will return for investigation.Verbatim: a user facility biomedical technician reported to customer service that when they took the syringe out of the box it was broken in the wrap.There was no patient involvement, no patient harm or adverse event reported at intake.
Event or Problem Description
It was reported that an unspecified number of syringe 10ml ll w/ndl 20x1 rb experienced product damage/deformation with the device still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 309644 batch no.: 4139688.Clarification: upon speaking with the customer, he reported the box was ripped, syringes were missing and there was a big blue sticker on the box.He could not determine if the box came from a distributor or bd that way.He states he still has the box and will return for investigation.Verbatim: a user facility biomedical technician reported to customer service that when they took the syringe out of the box it was broken in the wrap.There was no patient involvement, no patient harm or adverse event reported at intake.
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.

• Brand Name: SYRINGE 10ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9806101
• Report Number: 1213809-2020-00173
• Device Sequence Number: 11615079
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/20/2020

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 Expiration Date: 04/30/2019
• Device Model Number: 309644
• Device Catalogue Number: 309644
• Device Lot Number: 4139688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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