MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303401
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd 3ml syringe w/ luer-lok¿ tip with vial access cannula plunger rod was damaged and leaked.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: 303401, batch no: 9060931.It was reported that plunger is not flush inside the barrel, causing the syringe to leak.Per customer email: there seems to be an issue with the bd 3ml syringe ref # 303401 (p/s 27638).Put in a safety net complaining that the medication is leaking out of the syringe on a few occasions.After physically looking at the syringe she handed me, i noticed that the plunger is not flush inside the barrel.
Additional Manufacturer Narrative
H.6.Investigation summary: five 3ml syringes with needle in blister packs from batch 9060931 (p/n 303401) were received and evaluated.It was observed one of the packages was opened and four were fully sealed.The syringe in the opened package appeared to have an insecure stopper condition where the stopper was not fully seated on the end of the plunger rod and was rejectable per product specification.The other four samples had no visual defects.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.Potential root cause for the insecure stopper defect is associated with the assembly process.Most likely there was a misalignment between the plunger rod and stopper dial.No corrective actions are necessary based on the defective rate identified.Batch 9060931 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that bd 3ml syringe w/ luer-lok¿ tip with vial access cannula plunger rod was damaged and leaked.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: 303401 batch no: 9060931.It was reported that plunger is not flush inside the barrel, causing the syringe to leak.Per customer email: there seems to be an issue with the bd 3ml syringe ref # 303401 (p/s 27638).Put in a safety net complaining that the medication is leaking out of the syringe on a few occasions.After physically looking at the syringe she handed me, i noticed that the plunger is not flush inside the barrel.

• Brand Name: BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8769117
• Report Number: 1213809-2019-00711
• Device Sequence Number: 16737088
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• 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): 08/12/2019

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: 01/31/2024
• Device Catalogue Number: 303401
• Device Lot Number: 9060931
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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