MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ BLUNT FILL NEEDLE; PISTON SYRINGE

Catalog Number	305064
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/14/2018
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 "more than 50" of the bd luer-lok¿ blunt fill needles were found right out of the packaging with no scale markings on the syringes, being "completely clear no writing on it at all".
Additional Manufacturer Narrative
Investigation summary: dhr: release date: (b)(6)2018.Released quantity was (b)(4).All visual inspections were performed as per requirement.A quality notification was issued for missing print during the manufacture of the batch.Adjustments were made and product requalified per applicable aql before production resumed.Batch 8154719 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.One 10ml ll syringe with needle in an opened blister pack of batch #8154719 (p/n 305064) was received and visually inspected.It was observed that the syringe was blank with no visible scale markings.Potential root cause for the missing scale defect is associated with the ink flow failure during the marking process.No corrective actions are necessary based on the defective rate identified.
Event or Problem Description
It was reported that "more than 50" of the bd luer-lok¿ blunt fill needles were found right out of the packaging with no scale markings on the syringes, being "completely clear no writing on it at all".

• Brand Name: BD LUER-LOK¿ BLUNT FILL NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8244477
• Report Number: 1213809-2018-01024
• Device Sequence Number: 1594210
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 305064
• Device Lot Number: 8154719
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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