MAUDE Adverse Event Report: NEO MEDICAL, INC. PRO SAFETY GWI NEEDLE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number SPG-202-32-07

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: 1) call (b)(4) was received indicating that finished good spg-101-21-07, (b)(4) pro safety gwi needle, had a breakage occur resulting in a needle stick.2) the product is identified within the master planning as a "relabel" device supplied by ca-neo medical, inc.(b)(4) was issued.The qc complaint specialist followed up with the vendor on (b)(4) 2015 as a reminder of the approaching scar due date.Ca-neo medical, inc.Supplied the scar response on (b)(4) 2015.Refer to the (b)(4) call (b)(4) attachment.3)the qc complaint specialist reviewed the qfi report for sales and similar complaint information.(b)(4).No previous reports have been received for the reported issue.4) deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue.Correction: a correction has not been taken.Root cause analysis: scar: unknown.No product was available for inspection or review.Deroyal: the reported issue has been determined to be an isolated event due to an undetermined true root cause.A lot number was not reported and a sample has not been provided for evaluation.Corrective action and/or systemic correction action taken: no actions were taken or required by our capa system due to this being the first reported incident of this nature out of (b)(4) units sold since 2008.Preventive action: scar: a preventive action has not been taken.Investigation is complete at this time.This report will be updated as more information becomes available.Device discarded by user.

Event Description

The nurse used the needle.Then when she went to slide the sheath over the needle.At that point, the sheath was completely extended, and the plastic sheath broke at the base of the needle.The nurse's hand bounced back after the sheath broke and stuck her hand.The patient had c.Diff.The nurse was treated with prevention drugs and medical care.

• Brand Name: PRO SAFETY GWI NEEDLE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): NEO MEDICAL, INC.; 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: 5135311
• MDR Text Key: 28158870
• Report Number: 1060680-2015-00042
• 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: Nurse
• Report Date: 10/06/2015

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?: No
• Device Operator: Nurse
• Device Catalogue Number: SPG-202-32-07
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention