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

Catalog Number	309644
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
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 during use of the bd luer-lok¿ syringe with bd precisionglide¿ needle ¿the clinical manager reported that when the bd syringe needle was inserted into vial to draw up medication, the needle separated from the hub and stuck in the rubber stopper of the medication vial.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: a single black and white photo was received depicting two heparin medicine vials with needle cannulas sticking out of the vials¿ stoppers.The product was reported to be from batch #7210935 (p/n 309644).One vial was almost empty of liquid and one vial was more than half full of liquid.The cannulas in the photo are by themselves without the needle hubs and syringes.The cannulas are visibly inserted at an angle into the stoppers at approximately 30-45 degrees.A needle which separates from the needle hub is a rejectable condition.However, it appears that the needles were inserted into the vials at a large angle, instead of perpendicular to the stopper, which potentially contributed to the failure.Since no samples were returned and the photo is of poor quality, further investigation is not possible.Based on the available information, the failure cannot be attributed to the manufacturing process.Dhr review for batch 7210935 (p/n 309644): manufacturing dates: 08/04/2017 to 08/05/2017.Batch quantity was 360,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7210935 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Bd canaan was not able to duplicate or confirm the customer's indicated failure.Root cause and capa not required based on severity and occurrence level defined for this complaint.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7389147
• Report Number: 1213809-2018-00210
• Device Sequence Number: 1007117
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 309644
• Device Lot Number: 7210935
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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