MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL; BARD-PARKER BLADE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/29/2018

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a letter from the fda (reference number mw5077361) indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.No sample and no photographic evidence was available for evaluation.A manufacturing lot number was also unavailable for review.Bard-parker size 11 scalpel tip broke off in the patient's neck during an emergent cricothyrotomy.The broken blade tip was successfully retrieved from the patient's neck in the or.The blade was not tagged or saved after the event.No additional treatment was required.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a ¿medio¿ blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user during surgery process could also cause blade condition.The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Based on this information, no further action is required.Device not available.

Event Description

Aspen surgical received a letter from the fda indicating that a bard-parker blade broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint (b)(4).Fda reference number is mw5077361.

• Brand Name: BARD-PARKER #11 PROTECTED DISPOSABLE SCALPEL
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 7620162
• MDR Text Key: 111703821
• Report Number: 1836161-2018-00073
• 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: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• 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