MAUDE Adverse Event Report: DANNIK, LLC PMI SUPERBAG; SPECIMEN RETRIEVAL BAG

Model Number	PNI2000
Medical Device Problem Codes	Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6), asked me to let you know that the pmi superbag pni2000 she used yesterday broke during deployment.One of the tines broke through the bag, which made it difficult to get the specimen inside the, now floppy, opening of the bag.This was also difficult because the tine wasn't covered by the bag and increased the risk of injuring patient tissue.Luckily, the patient wasn't harmed due to this but the risk was there.Per (b)(6), dr.(b)(6) wanted the manufacturer to know that a pni2000 superbag she used broke during deployment.One of the tines broke through the bag, which made it difficult to get the specimen inside the now floppy opening of the bag.This was also difficult because the tine wasn't covered by the bag and increased the risk of injuring the patient tissue.There was no patient harm, but the doctor felt that the risk was there.Where exactly along the length of the bag mouth did the arm come through the material? (i.E.Mid way, close to the introducer tube, close to the distal end of the bag).A: close to the distal end of the bag.How many times was the bag used? a: incident happened on the first usage.Was the bag attached to the arm prior to retraction into the introducer tube? a: it looked attached, yes.Was there any increase force or effort required during loading of the bag (retraction) or during deployment? a: unsure but looked normal from my circulator point of view.Was any part of the product saved or pictures taken? a: no.
Additional Manufacturer Narrative
Dannik has completed a thorough review of all available records related to this device and associated lot number including manufacturing and incoming inspection records for all subassemblies, components, and raw materials.This lot passed all manufacturing and quality control inspections, and no irregularities or abnormalities were found during the record review.Review of vigilance reports did not reveal any trends, as this is the first known occurrence of this issue to date.The suspect device was not retained, and no pictures were provided.Device retains from this lot were tested under normal and extreme operating conditions, and all tested devices functioned as expected.Two possible causes could not be ruled out, including aggressive deployment by the user and incorrect assembly of the bag tether within the device by the manufacturing technician.Dannik was unable to recreate the failure in either instance, but noted tension on the bag body where is it thought that the puncture occurred.Additionally, review of all current completed and in-process inventory found all units to be conforming and assembled correctly.Without pictures or the returned device, it is impossible to determine from the provided information the exact root cause.This event did not result in patient harm in this instance but has a probability to result in patient harm as the metal arm would no longer be contained by the mouth of the bag and may injure adjacent internal structures.Therefore, out of an abundance of caution dannik is notifying the appropriate regulatory authorities.Dannik will continue to monitor this issue through our vigilance system for trends and take appropriate actions as necessary to ensure the continued performance and safety of the product.If additional information regarding this incident is obtained which was not known or not available prior to this report, dannik will re-open and reassess our investigation and response at that time.

• Brand Name: PMI SUPERBAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): DANNIK, LLC; 3201 e. colonial dr.; suite m3; orlando FL 32803
• Manufacturer (Section G): DANNIK, LLC; 3201 e. colonial dr.; suite m3; orlando FL 32803
• Manufacturer Contact: daniel doerr ; 941 w. morse blvd.; suite 100; winter park, FL 32789 ; 3217501155
• MDR Report Key: 17268900
• Report Number: 3015775837-2023-00001
• Device Sequence Number: 6059114
• Product Code: GCJ
• UDI-Device Identifier: 00850013527649
• UDI-Public: 00850013527649
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K200053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Model Number: PNI2000
• Device Lot Number: 2212PNI200001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown