MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LS SP125; PISTON SYRINGE

Catalog Number	309647
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
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 the syringe 5ml ls sp125 packaging was not completely sealed and the product was found "falling out" before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "the packages are not completely sealed and the product is falling out.".
Event or Problem Description
It was reported that the syringe 5ml ls sp125 packaging was not completely sealed and the product was found "falling out" before use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "the packages are not completely sealed and the product is falling out".
Additional Manufacturer Narrative
Investigation: two photos of a 5ml syringe in an opened blister pack were received and evaluated.It was observed where the package was opened, the seal was not well pronounced.The open seal defect was rejectable per product specification.Potential root cause for the open seal defect is associated with the equipment failure.There was a poor connection between the heat regulating component and the sealing station.As corrective action, a more secure connection of the wiring between components and/or a detection method for improper connections will be reviewed.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 5ML LS SP125
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9354781
• Report Number: 1213809-2019-01151
• Device Sequence Number: 10929501
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: 30382903096474
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 03/31/2024
• Device Catalogue Number: 309647
• Device Lot Number: 9115907
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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