MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER; BLADE, SCALPEL

Catalog Number 371111

Device Problems Corroded (1131); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Bard-parker surgical blades have corrosive area on blade once exposed to fluids.The color of the blade changed to grayish-black.Blade was in acs vascular pack.Staff and surgeons state that other blades have had this also - in sterilized surgical packs and from individual packages from shelf.

• Brand Name: BARD-PARKER
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6993348
• MDR Text Key: 90805294
• Report Number: 6993348
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 371111
• Device Lot Number: 0127507
• Other Device ID Number: #11 CARBON RIB-BACK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLUIDS THAT MAY HAVE CONTRIBUTED TO RUST FORMATION; OTHER, FLUIDS