MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS; MARKING PEN

Model Number 2650

Device Problem Defective Device (2588)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was returned for evaluation.The manufacturing lot number along with samples were provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the samples confirmed the issue from the distributor.Analysis of the finished good lot number was reviewed.No non-conformance's were noted during the manufacturing process.The sample review showed that the patient label or ruler being caught in the seal and not seated within the pocket.Patient labels and rulers are auto-loaded, which dispenses each component into the pocket.The auto-loader is programmed per recipe which is depended on the patient label and ruler quantity.If there was a fault in the loader all pockets would express the same failure, however, the cylinders that were being used at the time these lots were created was dropping the parts from too high of a height.This caused some parts to not be dropped directly in the pouch.The two reported lots were packaged prior to the update to the new pneumatic cylinder update, which will allow more control of the part drop height into the pocket to allow for better part placement in the pocket.Therefore, the root cause is attributed to a machine issue.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a marking pen was found with defective seals.The item was not in use.No injury/death was reported.Customer reported multiple lots for the same issue.The lot numbers, and their respective complaint numbers are as follows: (b)(4).

• Brand Name: RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS
• Type of Device: MARKING PEN
• 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: 10540563
• MDR Text Key: 208845512
• Report Number: 1836161-2020-00042
• Device Sequence Number: 1
• Product Code: FZZ
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2650
• Device Lot Number: SEE ABOVE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• 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