MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L.R. #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, N; BLADE, SCALPEL AND HANDLE, SCALPEL, GES, GDZ

Catalog Number D4511A

Device Problems Human-Device Interface Problem (2949); Device Handling Problem (3265)

Patient Problems Needle Stick/Puncture (2462); No Patient Involvement (2645)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

The nurse stated went to pick up the blade and the blade was sticking out of the safety sleeve.This was reported on the angio adult safety pack.There is injury reported.Clinical data requested due to the nature of the complaint.

Manufacturer Narrative

Investigation findings: deroyal manufactured (b)(4) cases of finished good d4511a and would contain a total of (b)(4) each of the raw material.There have been no add'l complaints received from alternate deroyal customers in which the device was found unacceptable; the work order review was conducted adn ti was identified that the routine provides instructions for the mfg facility to ensure the blades are retracted during the mfg process.Refer to the below routing instructions; within the in-process inspection documentation the mfg facility rejected a total of (b)(4) each of the scalpels during the mfg process.A total of (b)(4) each were rejected due to the exposed blade and (b)(4) each rejected due to being broken.Refer to the wo (b)(4) and re assistance attachment was evidence of this review; the qc complaint specialist has been in contact with the reporting customer to obtain add'l info in reference to their mfg process due to the product being removed from the deroyal packaging and placed into a custom kit by cardinal health.It is unk if during this handling process if the slider is inadvertently put within the slide position versus the secure position.Vendor contact, (b)(4) verbally stated within a phone call, "here is no set standard as to the orientation of the device within their product.The blade could be within the upward and downward position and surrounded by alternate products.This issue is not being noticed by the pullers during the pulling process.".

• Brand Name: #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, N
• Type of Device: BLADE, SCALPEL AND HANDLE, SCALPEL, GES, GDZ
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.L.R.; km7, autopista joaquin balaguer; pisano free zone, bldg 49; santiago ; DR
• Manufacturer Contact: 200 debusk ln; powell, TN 37849 ; 8653622333
• MDR Report Key: 4385177
• MDR Text Key: 5124736
• Report Number: 3004605321-2014-00003
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D4511A
• Device Lot Number: 36173481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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