MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE; BARD-PARKER BLADE

Model Number 371115-150

Device Problem Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The distributor indicated in report that no sample was available for evaluation, only the manufacturing lot number was provided for review.Particles from a bard-parker blade size 15 was reported to have fallen into the wound during a bunionectomy.The surgeon irrigated the wound to flush out any particles from the blade.The patient tolerated well and follow up care was not required.Based on the evaluation conducted, lot 0146444 was packed per dhr and no non-conformance related to this issue were present.Packing process has established controls to mitigate the condition, including a blade sensor that inspect 100% of packed pouches liner level prior to aluminum foil packaging.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.

Event Description

Aspen surgical received a report from the distributor indicating that particles from a bard-parker blade fell in the patient during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as (b)(4).

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
• 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: 7316765
• MDR Text Key: 101606772
• Report Number: 1836161-2018-00030
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371115-150
• Device Lot Number: 0146444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Other; Required Intervention