MAUDE Adverse Event Report: MICROVENTION, INC SOFIA 5F 115 CM STR; PERCUTANEOUS CATHETER

Model Number	DA5115ST
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is underway.
Event or Problem Description
It was reported that the sofia catheter was removed from its box and a small tear was observed in the top of the plastic sterile packaging.There was no patient involvement.
Additional Manufacturer Narrative
The damaged package was returned for evaluation.Visual inspection of the returned package confirmed a 0.424" slit in the pouch.The investigation could not determine the conditions or circumstances that led to the damage, but it is consistent with mishandling.Per quality control processes, all packaging is 100% visually inspected on both sides to identify pinholes, lacerations, tears and any irregularities in the material such as indentations or protrusions which could indicate any pinholes, tears, lacerations, etc.The root cause for the damage could not be determined.

• Brand Name: SOFIA 5F 115 CM STR
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9892279
• Report Number: 2032493-2020-00077
• Device Sequence Number: 19560663
• Product Code: DQY
• UDI-Device Identifier: 00812636020082
• UDI-Public: (01)00812636020082(11)190902(17)220831(10)19090257H
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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 Expiration Date: 08/31/2022
• Device Model Number: DA5115ST
• Device Catalogue Number: DA5115ST
• Device Lot Number: 19090257H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1