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	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2020
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.(b)(4).
Event or Problem Description
It was reported that an unspecified number of 10 ml bd luer-lok syringes with bd precisionglide needles experienced a needle that was loose/pulled out of hub during use.The following information was provided by the initial reporter: material no.309644, batch no.9346089.A peritoneal dialysis (pd) patient contacted customer service to report that they are having issues with the luer lok syringe.When they pull the cap off, the needle comes off along with the cap so she has to hold the bottom part.There was no patient harm or adverse event reported at intake.
Additional Manufacturer Narrative
H.6.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
It was reported that an unspecified number of 10 ml bd luer-lok¿ syringes with bd precisionglide¿ needles experienced a needle that was loose/pulled out of hub during use.The following information was provided by the initial reporter: material no.(b)(6) batch no.9346089.A peritoneal dialysis (pd) patient contacted customer service to report that they are having issues with the luer lok syringe.When they pull the cap off, the needle comes off along with the cap so she has to hold the bottom part.There was no patient harm or adverse event reported at intake.

• 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: 10370266
• Report Number: 1213809-2020-00513
• Device Sequence Number: 3860005
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 309644
• Device Catalogue Number: 309644
• Device Lot Number: 9346089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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