MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA¿ SYRINGE

Catalog Number	305283
Health Effect - Clinical Code	Underdose (2542)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 3 ml bd integra¿ syringe failed, "it appears that the retractable component has pierced through the rubber stopper".Furthermore "the nurse was not able to give the complete dose." no serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: yes.
Event or Problem Description
It was reported that 3 ml bd integra¿ syringe failed, "it appears that the retractable component has pierced through the rubber stopper".Furthermore "the nurse was not able to give the complete dose." no serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Two sealed 3ml integra packaged syringes, one open 3ml integra packaged syringe and one loose syringe was received and confirmed to be from batch #6320741 (p/n 305283).All samples were syringe only, no needle was attached.The samples were visually evaluated.Additionally, two pictures were also received, both pictures appear to be of the loose syringe received.The sealed syringes - no visual defects.One open syringe ¿ no visual defects.One loose syringe ¿ trace liquid in syringe.Cutter is exposed through stopper as expected during activation.Plunger assembly is at half scale of syringe thumb rest not depressed.No visual defects observed.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.No root cause is defined since samples received did not display the reported condition involved with this complaint.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 3 ml bd integra syringe failed, "it appears that the retractable component has pierced through the rubber stopper".Furthermore "the nurse was not able to give the complete dose." no serious injury or medical intervention was reported.

• Brand Name: 3 ML BD INTEGRA¿ SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7673091
• Report Number: 1213809-2018-00402
• Device Sequence Number: 1553881
• Product Code: FMF
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: No Information
• Device Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/15/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/06/2018; 09/13/2018
• 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