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

Model Number ST-100

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that the seal of a scalpel holder pouch was compromised.The item was not in use and no injury/death was reported.A sample was available for evaluation.A manufacturing lot number was 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 confirmed the seal issue.Upon review, the tyvek seal paper was not aligned with the film pocket causing the seal to not fully form.This occurs during startup or material change to be completed by operators per specified work instructions.Therefore, the root cause contributing to the event was due to operating error.Additionally, the pouch label identifies this 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 a scalpel holder was discovered with a seal issue.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, SERILE
• 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: 10706154
• MDR Text Key: 214598980
• Report Number: 1836161-2020-00054
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 221822
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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