MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA SCALPEL HOLDER RED, ASPEN LEAF WITH BARD-PARKER, STERILE

Model Number ST-100

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that the pouch of a scalpel holder was discovered with a defect.The item was not in use and no injury/death was reported.Sample was available for evaluation.Photographic evidence along with manufacturing lot number was also provided for review.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.A review of the sample and photo confirmed the issue was present on the product.Two unopened pouches were received.Both pouches had red splice tape packaged in the seal of the pouch.Product is manually loaded into recessed pockets.When the pouch film nears its end, operators replace the material and use red tape to splice the material together.When this occurs, operators remove the spliced material and scrap it prior to the pouch reaching the packaging area.Therefore, the root cause for this reported defect can be attributed to a failure to monitor and scrap these pouches.Operations was notified of this reported issue.Additionally, the pouch label identifies a packaging failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that the pouch of a scalpel holder was discovered with a sealing defect.The item was not in use and no injury/death was reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: SCALPEL HOLDER RED, ASPEN LEAF WITH BARD-PARKER, STERILE
• Type of Device: SCALPEL HOLDER
• 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: 8216755
• MDR Text Key: 132220690
• Report Number: 1836161-2019-00003
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ST-100
• Device Lot Number: 167335
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• 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