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

Catalog Number	309632
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
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 that before use of the bd syringe with bd precisionglide¿ needle had black spots on the seal.
Event or Problem Description
It was reported that before use of the bd syringe with bd precisionglide¿ needle had black spots on the seal.
Additional Manufacturer Narrative
H.6.Investigation: a total of 478 samples in 2 opened and 3 sealed shelf cartons were received, containing sealed packaged product confirmed to be from batch #8243753 (p/n 309632).The samples were visually evaluated.252 packages contained no foreign matter.162 packages contained small loose black foreign matter specks inside the packages outside the fluid path.The foreign matter in these packages was smaller than level 3 in size and acceptable per product specification.64 packages were found to contain foreign matter particles larger than level 3 in size which are rejectable per product specification.The particles were inside the packages outside the fluid path.All of the affected packages were from cavities 1 through 8.Per fourier transform infrared analysis the foreign matter was identified to be most likely polyethylene.The packaging cavities 1 through 8 are all packaged on one side of the packaging machine.The packaging process was thoroughly evaluated for any abnormalities.A hard polyethylene cable wrap was identified as a potential source of the foreign matter as it interacts with a machine guard.The wrap was being damaged through friction with the guard edge, creating particulates in the process.The particulates could then collect on the guard and be inadvertently introduced into packages during any human intervention in that area of the machine.Potential root cause for the foreign matter particulate is likely associated with the polyethylene cable wrap material and its setup.Corrective action: (1) the immediate setup was corrected to reduce friction.(2) polyethylene cable wrap will be replaced with high density polyethylene material.(3) the setup of the cables will be improved to greatly reduce friction to eliminate or greatly reduce particulate creation long term.A dhr was performed for this lot.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8243753 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

• Brand Name: BD 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: 8103006
• Report Number: 1213809-2018-00819
• Device Sequence Number: 19424120
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 07/31/2023
• Device Catalogue Number: 309632
• Device Lot Number: 8243753
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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