MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; SAFETY ENGINEERED SYRINGE AND NEEDLE

Catalog Number	309596
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2018
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 safety-lok¿ syringe with detachable needle had scale marking issues found before use.There was no report of injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation conclusion: seven samples were received, six of them were in sealed packages and one was loose without the package.Samples were confirmed to be from lot 7212671.The samples were visually evaluated, these samples have no legible scale mark, thus, the defect noted by end user, can be confirmed.Manufacturing date for batch 7212671: 08/04/2017-08/06/2017, batch size was (b)(4).A quality notification was created on 8/04/2017 due to blank barrels found during processing, affected product was scraped and machine adjustments were performed prior to resume production.Batch 7212671 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: the defect is confirmed based on sample evaluation.Root cause is undetermined.

• Brand Name: BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: SAFETY ENGINEERED SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7275227
• Report Number: 1213809-2018-00039
• Device Sequence Number: 13954794
• Product Code: FMI
• UDI-Device Identifier: 00382903095964
• UDI-Public: 00382903095964
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• 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): 03/21/2018

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: 309596
• Device Lot Number: 7212671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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