MAUDE Adverse Event Report: PENSAR MEDICAL PENSAR MEDICAL MINI STINGRAY CONNECTOR; NEGATIVE PRESSURE WOUND THERAPY KIT

Model Number	0810
Medical Device Problem Codes	Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer medco - reported quality issues with the woundpro mini stingray.(p/n 0810, lot 1608); the stingray polymer connector had visible "cracking".After one product in use exhibited a leak, the products (10 units each per case, 40 units total) were eaxmanined outside clinical use to assess others which may have any visble defects.Approximately 10 of the 40 units were suspect of potential issue and were discarded and replaced by pensar.The leak of the clinical use component did not prevent or therepy, but a dressing change was completed to eliminate any potential issue.Devices were not returned.No patient harm or event was reported.Conservative determination: mdr reportable.
Additional Manufacturer Narrative
Pensar attempted to obtain the omitted information 1.Patient information a1-a6.2.B6 relevant test labs - n/a.3.B7 other relevant history -n/a.4.D10 date of concomitant therapy - unkknown.The "stingray" connector that adapts the hose to the dressing was noted to be cracking on some product.Product is supplied as 10 each per case.Customer evaluated all product on hand and found approximately 10 of 40 that had potential visible effects, though they were not tested to confirm any loss of performance beyond visual inspection.Product was not returned for evaluation, additional product provided to the distributor/user as replacement.This report is being submitted based on re-evaulation of reportability requirements per pensar capa 46.

• Brand Name: PENSAR MEDICAL MINI STINGRAY CONNECTOR
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY KIT
• Manufacturer (Section D): PENSAR MEDICAL; 109 n post oak ln; suite 525; houston TX 77024
• Manufacturer (Section G): PENSAR MEDICAL; 109 n post oak ln; suite 525; houston TX 77024
• Manufacturer Contact: jon olson ; 109 n post oak ln; suite 525; houston, TX 77024 ; 2142881035
• MDR Report Key: 25566652
• Report Number: 3007793449-2024-00005
• Device Sequence Number: 9996079
• Product Code: OMP
• UDI-Device Identifier: 00851978007405
• UDI-Public: 00851978007405
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0810
• Device Catalogue Number: 8463540 0810
• Device Lot Number: 1608
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PENSAR WOUNDPRO NPWT PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown