MAUDE Adverse Event Report: TIDI PRODUCTS, LLC TIDI PRODUCTS LLC, PEN BLADE; SCALPEL, ONE-PIECE

Model Number PBNS11ACTN

Device Problem Mechanical Jam (2983)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product was returned for evaluation.However, the results of the investigation are pending.Note that this specific part number is not sold as for use in medical settings.It is same or similar design to sterile medical blades also sold by tidi and therefore could experience a similar defect.If the product doesn't retract as intended, then the product is putting clinicians at risk for a sharps injury even though other safety practices are in place.Historical complaint data review found two other similar complaints documented for this product in the last two years.A capa that was opened at that time identified the root cause of the nonconformance to be an inadequate or defective mold design of the slide, with defective units exhibiting excessive material on the slide/blade connection.Corrective action was to change the slide mold design.Implementation of corrective actions was completed in august of 2020.Lot information is not available at this time, therefore manufacturing documentation could not be pulled for review.It is possible that these units were manufactured before corrective action was fully implemented.Investigation and evaluation of returned product is in process.No further corrective or preventative actions are necessary at present.All complaints are trended and reviewed by management on a monthly cadence.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as appropriate.Manufacturer reference file # (b)(4).

Event Description

Email and called from customer has 175 eaches with blades that are stuck and non-retractable.Wants 175 each replacement.All 175 in some master cartons.

Event Description

Email and call from customer has 175 eaches with blades that are stuck and non-retractable.Supplemental medwatch being sent for additional information.

Manufacturer Narrative

H6: while this part number is not used in medical settings, it is the same or similar to its sterile medical blade counterpart and therefore could experience a similar defect.Interference testing has determined it likely that the shell rails are interfering with the slide and causing the device to delay and or not retract.Additionally, there was a single instance of the blade connection rubbing at the distal tip of the housing.The latest slide mold modification was implemented, modifying the railings to decrease interfacing with the slide, after these units were built to mitigate this interference by reducing the plastic build up along the blade connection.This slide mold was verified and met all product specifications.This failure mode has been noted historically and actions have been taken to decrease the rate of failure.Further testing is currently being conducted on different sample populations to investigate the factors leading to delayed retraction or no retraction.No further corrective action is required at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference (b)(4).

• Brand Name: TIDI PRODUCTS LLC, PEN BLADE
• Type of Device: SCALPEL, ONE-PIECE
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 8207514300
• MDR Report Key: 13026665
• MDR Text Key: 286666572
• Report Number: 2182318-2021-00014
• Device Sequence Number: 1
• Product Code: GDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PBNS11ACTN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1