MAUDE Adverse Event Report: NEO MEDICAL SHARPS SAFETY GUIDEWIRE INTRODUCER NEEDLE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number SPG-101-18-07

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause analysis: the true root cause of the reported issue has not been determined.(b)(4) supplies the finished good to deroyal, and thus, a supplier corrective action request (scar) has been issued to (b)(4) as well as the returned sample for evaluation.At this time, deroyal has not received the results of the sample evaluation or a scar response.Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating the reporting customer has experienced failures with the safety mechanism of a guidewire introducer needle (part number spg-101-18-07).The needle is getting stuck in the hub when attempting to activate the safety mechanism/sheath cover.(b)(4) supplies the finished good to deroyal.A sample was returned to deroyal for evaluation.An unknown substance was present on the sample, and therefore, the sample was treated as biohazardous.The vendor was contacted in reference to the sample and requested it be properly identified as a biohazard and shipped directly to (b)(4) attention.Decontamination was not requested.The sample was shipped to (b)(4) on 12/04/2015.The quality control complaint specialist reviewed the 2013 to 2015 scar and supplier notification letter (snl) logs for similar complaints.There have been no previous complaints for the failure mode identified, but due to the nature of the report, (b)(4) was issued to (b)(4).The supplier corrective action request due date is 1/7/2016.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is ongoing.This report will be updated when new and critical information is available.

Event Description

Site has had a couple of failures on this safety device where the needle is getting stuck in the hub when activating safety mechanism/sheath covering needle.

• Brand Name: SHARPS SAFETY GUIDEWIRE INTRODUCER NEEDLE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): NEO MEDICAL; 1375 greg st, ste. 108; sparks NV 89431
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5306897
• MDR Text Key: 33783845
• Report Number: 1060680-2015-00048
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SPG-101-18-07
• Device Lot Number: 1019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1