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

Catalog Number	309569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd luer-lok syringe with precisionglide ¿ needle had twisted hubs causing the needle to bend when used, this could lead to possible leakage.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that bd luer-lok syringe with precisionglide ¿ needle had twisted hubs causing the needle to bend when used, this could lead to possible leakage.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one photo depicting a 3ml syringe with needle.The needle hub is twisted/damaged.The twisted hub/damage observed is rejectable per product specification.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.Investigation conclusion: potential root cause for the twisted hub defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

• Brand Name: BD LUER-LOK SYRINGE WITH 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: 7742185
• Report Number: 1213809-2018-00481
• Device Sequence Number: 16570465
• Product Code: FMF
• UDI-Device Identifier: 30382903095699
• UDI-Public: 30382903095699
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/28/2018

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: 04/30/2023
• Device Catalogue Number: 309569
• Device Lot Number: 8106769
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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