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

Catalog Number	309592
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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 out of 2 boxes, 15 bd safety-lok¿ syringes with detachable needles were found with foreign matter "appears to be ink or paint spots" inside and outside of the barrel.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: sample evaluation: a bag contained two loose 3ml safetylok syringes was received, reported to be from batch # 7260819 (p/n 309592).The samples were visually evaluated.Ink smear was observed on both syringes on flange and barrel wall outside of fluid path.The size of the ink mark was greater than level 3, which is rejectable per product specification.Product defect confirmed based on sample evaluation.Dhr review for batch 7260819 (p/n 309592): manufacturing dates: 09/20/2017 to 09/21/2017.Batch quantity was 216,000.Printing and assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7260819 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: product defect confirmed based on sample evaluation.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.

• Brand Name: BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: SYRINGE WITH HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7559033
• Report Number: 1213809-2018-00326
• Device Sequence Number: 16630782
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: 30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 08/31/2022
• Device Catalogue Number: 309592
• Device Lot Number: 7260819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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