MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309644
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.309644 batch no.7210934.It was reported that after use of the 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle an expired needle was used for two weeks.The following information was provided by the initial reporter: "a contact for peritoneal dialysis patient contacted customer service to report that the patient was unaware and was using the expired needle for the last 2 weeks.There was no patient harm or adverse event reported.".
Additional Manufacturer Narrative
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.
Event or Problem Description
Material no.309644 batch no.7210934.It was reported that after use of the 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle an expired needle was used for two weeks.The following information was provided by the initial reporter: "a contact for peritoneal dialysis patient contacted customer service to report that the patient was unaware and was using the expired needle for the last 2 weeks.There was no patient harm or adverse event reported.".

• Brand Name: 10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9448973
• Report Number: 1213809-2019-01252
• Device Sequence Number: 14087192
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: 309644
• Device Catalogue Number: 309644
• Device Lot Number: 7210934
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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