MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE; 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	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd luer-lok¿ syringe with bd precisionglide¿ needle leaked around the hub during use while drawing up medication.This occurred on 2 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "pharmacist called on behalf on consumer, stated when the consumer was drawing his medication, he noticed leakage around the hub.Stated, the patient was not able to use the syringes 2 syringes affected.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.Unfortunately, physical unused samples are necessary for leakage testing.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with bd precisionglide¿ needle leaked around the hub during use while drawing up medication.This occurred on 2 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "pharmacist called on behalf on consumer, stated when the consumer was drawing his medication, he noticed leakage around the hub.Stated, the patient was not able to use the syringes 2 syringes affected".

• Brand Name: 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: 10070247
• Report Number: 1213809-2020-00316
• Device Sequence Number: 11490825
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Model Number: 309644
• Device Catalogue Number: 309644
• Device Lot Number: 9288568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 05/28/2020
• 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