MAUDE Adverse Event Report: OWENS & MINOR IHALYARD MANUAL SURGICAL INSTRUMENT FOR GENERAL USE; INST: SCALPEL METAL NUM 10 20/BX

Model Number 56214

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 12jan2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by owens & minor, inc.Represents all of the known information at this time.Owens & minor, has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the owens & minor complaint database and identified as complaint (b)(4).

Event Description

Mai complaint number - (b)(4).Before performing a procedure on a patient, the health care provider had to use extreme excessive force to remove the plastic covering of blade and was cut in the left hand when trying to remove this covering.Per the customer, "provider will need 48 hour wound check, after receiving # 5 sutures (b)(6) 2020, day of receiving laceration injury from described incident, above, and said provider will need sutures removed 9-11 days after sutures applied.Provider made incident report to (b)(6) on day of injury, (b)(6) 2020.The scalpel that i was cut by, after excessive force removing the "point protector", is on the left.The plastic cover is 3 notches down, covering the handle, versus the other scalpel is not down as far, and just covering handle flat area." no patient involvement.Hibc/gtin of product: (b)(4).

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The photos of the kit labeling for both complaint lots, as well as a close-up photo of two unopened packages compared two scalpels, one showed the point protector farther down on the handle than the other scalpel.At the time of complaint receipt, inventory of the complaint kit lots and scalpel lots involved were depleted.A statistical sampling was performed on the current scalpel volume which is a different lot than the reported lot.All samples inspected met product specifications.The point protector was placed appropriately, and excessive force was not needed to remove the covering.A five-year complaint history of the kit (56214) as well as the kit lots associated with the complaint incident did not indicate any additional reports of an injury involving the scalpel or issues with the point protector.Based on our investigation and trending analysis, this complaint does not appear to be a widespread issue but isolated in nature.Actions taken: as part of our investigation process, a supplier corrective action request (scar) was issued to our scalpel supplier.If samples are received at a later date, we will forward to our supplier for examination.This complaint has been logged in our complaint database where we will continue to monitor for any related trends.All information reasonably known as of 29jan2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by owens & minor represents all of the known information at this time.Owens & minor has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the owens & minor complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a owens & minor product is defective or caused serious injury.

• Brand Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Type of Device: INST: SCALPEL METAL NUM 10 20/BX
• Manufacturer (Section D): OWENS & MINOR IHALYARD; one edison drive; alpharetta GA 30005
• MDR Report Key: 11158175
• MDR Text Key: 226629150
• Report Number: 1030451-2021-00001
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 20809160003760
• UDI-Public: 20809160003760
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/14/2022
• Device Model Number: 56214
• Device Catalogue Number: 56214
• Device Lot Number: 240862
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other